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Acetaminophen (paracetamol) and pamabrom: Drug information

Acetaminophen (paracetamol) and pamabrom: Drug information
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For additional information see "Acetaminophen (paracetamol) and pamabrom: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Cramp Tabs [OTC] [DSC];
  • Midol Caffeine Free [OTC];
  • Tylenol Women’s Menstrual Relief [OTC] [DSC]
Brand Names: Canada
  • Painaid PMF Premenstrual
Pharmacologic Category
  • Analgesic, Nonopioid;
  • Diuretic, Combination
Dosing: Adult
Menstrual symptoms

Menstrual symptoms: Oral: Two tablets (acetaminophen 650 mg/pamabrom 50 mg) every 4 to 6 hours as needed; maximum: 8 tablets (acetaminophen 2,600 mg/pamabrom 200 mg) per day.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

Children ≥12 years: Refer to adult dosing.

Adverse Reactions

See Acetaminophen monograph.

Contraindications

OTC labeling: When used for self-medication, do not use with other drug products containing acetaminophen.

Warnings/Precautions

Concerns related to adverse effects:

• Hepatotoxicity: Acetaminophen may cause hepatic toxicity with acute overdose; in addition, chronic daily dosing has resulted in liver damage in some adults.

• Hypersensitivity/anaphylactic reactions: Hypersensitivity and anaphylactic reactions have been reported; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur.

• Skin reactions: Rarely, acetaminophen may cause serious and potentially fatal skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Discontinue treatment if severe skin reactions develop.

Disease-related concerns:

• Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥3 alcoholic drinks/day may increase the risk of liver damage. Have patients avoid ethanol or limit to <3 drinks/day.

Special populations:

• Pediatric: Not for use in children <12 years of age.

Other warnings/precautions:

• Dosage limit: Limit acetaminophen dose to <4 g/day in adults.

• Self-medication (OTC use): Prior to self-medication, patients should contact health care provider if they have had liver disease. Advise patients to discontinue use and contact health care provider if new symptoms occur, if redness or swelling occurs, fever lasts >3 days, or pain lasts >10 days.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Cramp Tabs: Acetaminophen 325 mg and pamabrom 25 mg [DSC]

Midol Caffeine Free: Acetaminophen 500 mg and pamabrom 25 mg

Tylenol Women’s Menstrual Relief: Acetaminophen 500 mg and pamabrom 25 mg [DSC]

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Ms-Aid Oral)

500-25 mg (per each): $0.09

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Painaid PMF Premenstrual: Acetaminophen 500 mg and pamabrom 25 mg

Use: Labeled Indications

Menstrual symptoms: Temporary relief of symptoms associated with premenstrual and menstrual symptoms (eg, cramps, bloating, water-weight gain, headache, backache, minor aches and pains, swelling, feeling full sensation).

Medication Safety Issues
Other safety concerns:

Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alcohol (Ethyl): May increase hepatotoxic effects of Acetaminophen. Risk C: Monitor

Atazanavir: May increase serum concentration of UGT1A1 Substrates. Management: Do not use UGT1A1 substrates for which small increases in exposure can cause serious adverse effects together with atazanavir, and use caution with any UGT1A1 substrate, even when small changes in exposure are less likely to cause serious adverse effects. Risk D: Consider Therapy Modification

Belumosudil: May increase serum concentration of UGT1A1 Substrates. Management: Avoid coadministration of belumosudil with substrates of UGT1A1 for which minimal concentration increases can cause serious adverse effects. If coadministration is required, dose reductions of the UGT1A1 substrate may be required. Risk D: Consider Therapy Modification

Busulfan: Acetaminophen may increase serum concentration of Busulfan. Risk C: Monitor

CarBAMazepine: May increase metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor

Dapsone (Topical): May increase adverse/toxic effects of Methemoglobinemia Associated Agents. Risk C: Monitor

Dasatinib: Acetaminophen may increase hepatotoxic effects of Dasatinib. Dasatinib may increase serum concentration of Acetaminophen. Management: Avoid coadministration of acetaminophen and dasatinib if possible. If coadministration is unavoidable, monitor for signs/symptoms of hepatotoxicity, particularly in patients with greater acetaminophen exposure. Risk D: Consider Therapy Modification

Flucloxacillin: May increase adverse/toxic effects of Acetaminophen. Specifically, the risk for high anion gap metabolic acidosis may be increased. Risk C: Monitor

Fosphenytoin-Phenytoin: May decrease serum concentration of Acetaminophen. Specifically, serum concentrations of acetaminophen may be decreased (leading to decreased efficacy), but the formation of the toxic N-acetyl-p-benzoquinone imine (NAPQI) metabolite may be increased (leading to increased hepatotoxicity). Risk C: Monitor

Imatinib: Acetaminophen may increase hepatotoxic effects of Imatinib. Risk C: Monitor

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Acetaminophen may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Isoniazid: May increase hepatotoxic effects of Acetaminophen. Isoniazid may increase metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor

LamoTRIgine: Acetaminophen may decrease serum concentration of LamoTRIgine. Risk C: Monitor

Local Anesthetics: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor

Lorlatinib: May decrease serum concentration of Acetaminophen. Risk C: Monitor

MetyraPONE: May increase serum concentration of Acetaminophen. More importantly, by inhibiting the conjugative metabolism of acetaminophen, metyrapone may shift the metabolism towards the oxidative route that produces a hepatotoxic metabolite. Risk X: Avoid

Mitapivat: May decrease serum concentration of UGT1A1 Substrates. Risk C: Monitor

Nitric Oxide: May increase adverse/toxic effects of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor

PHENobarbital: May increase metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor

Phenylephrine (Systemic): Acetaminophen may increase serum concentration of Phenylephrine (Systemic). Risk C: Monitor

Prilocaine: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor for signs of methemoglobinemia when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid use of these agents with prilocaine/lidocaine cream in infants less than 12 months of age. Risk C: Monitor

Primaquine: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Primaquine. Specifically, the risk for methemoglobinemia may be increased. Management: Avoid concomitant use of primaquine and other drugs that are associated with methemoglobinemia when possible. If combined, monitor methemoglobin levels closely. Risk D: Consider Therapy Modification

Primidone: May increase metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor

Probenecid: May increase serum concentration of Acetaminophen. Probenecid may also limit the formation of at least one major non-toxic metabolite, possibly increasing the potential for formation of the toxic NAPQI metabolite. Management: Consider limiting acetaminophen use in combination with probenecid. Probenecid may reduce clearance of acetaminophen to one of its non-toxic metabolities, increasing the risk for acetaminophen toxicity, even a lower doses. Risk D: Consider Therapy Modification

RifAMPin: May increase hepatotoxic effects of Acetaminophen. RifAMPin may decrease serum concentration of Acetaminophen. Risk C: Monitor

Sodium Nitrite: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor

SORAfenib: Acetaminophen may increase hepatotoxic effects of SORAfenib. SORAfenib may increase serum concentration of Acetaminophen. Management: Avoid coadministration of acetaminophen and sorafenib if possible. If coadministration is unavoidable, monitor for signs/symptoms of hepatotoxicity, particularly in patients with greater acetaminophen exposure. Risk D: Consider Therapy Modification

Vaccines: Acetaminophen may decrease therapeutic effects of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider Therapy Modification

Vitamin K Antagonists: Acetaminophen may increase anticoagulant effects of Vitamin K Antagonists. This appears most likely with daily acetaminophen doses exceeding 1.3 or 2 g/day for multiple consecutive days. Risk C: Monitor

Pregnancy Considerations

Refer to individual monographs.

Breastfeeding Considerations

Refer to individual monographs.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CN) China: Ai jia;
  • (EG) Egypt: Acetoful for women | Jakmeston | Menobrocond | Womankit;
  • (IN) India: Mensodol | Pamamol | Pampra spas;
  • (KR) Korea, Republic of: Evefree | Women's tylenol tab | Womens tylenol;
  • (LV) Latvia: Fem-1;
  • (MX) Mexico: Syncol teen;
  • (MY) Malaysia: Actimol menstrual | Panadol menstrual | Uphamol menstrual;
  • (PK) Pakistan: Acepam | Febrol she | Nuberol she;
  • (RU) Russian Federation: Fem-1;
  • (SG) Singapore: Panadol menstrual;
  • (SR) Suriname: Women's tylenol multi symptom menstrual relief
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