Indications and uses
Uses for the temporary relief of these symptoms associated with menstrual periods: · cramps · bloating · water-weight gain · headache · backache · muscle aches
Uses for the temporary relief of these symptoms associated with menstrual periods: · cramps · bloating · water-weight gain · headache · backache · muscle aches
· do not take more than the recommended dose · adults and children 12 years and older: · take 2 caplets with water · repeat every 6 hours, as needed · do not exceed 6 caplets per day · children under 12 years: consult a doctor
Acetaminophen 500 mg
Pamabrom 25 mg
Acetaminophen 500 mg..............................…………………...Pain reliever
Pamabrom 25 mg……….………………………………………….…..Diuretic
Uses for the temporary relief of these symptoms associated with menstrual periods:
· cramps · bloating · water-weight gain
· headache · backache · muscle aches
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 6 caplets in 24 hours, which is the maximum daily amount
for this product
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
· skin reddening · blisters · rash
· hives · facial swelling · asthma (wheezing)
· shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
Do not use
· with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
· if you have ever had an allergic reaction to this product or any of its
ingredients
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
· new symptoms occur
· redness or swelling is present
· pain gets worse or lasts more than 10 days
· fever gets worse or lasts more than 3 days
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
· do not take more than the recommended dose
· adults and children 12 years and older:
· take 2 caplets with water
· repeat every 6 hours, as needed
· do not exceed 6 caplets per day
· children under 12 years: consult a doctor
Other informationstore at room temperature
Inactive ingredients carnauba wax, croscarmellose sodium, D&C red #7 calcium lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin
Questions or comments?1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-8030-24 | EA - Each | 0280-8030 | c18ef67d-3c0f-43ac-95ef-d440b766ba70 | 1 | 2016-07-19 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| PAMABROM | ACTIVE INGREDIENT | UA8U0KJM72 | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| BROMOTHEOPHYLLINE | ACTIVE MOIETY | FZG87K1MQ6 | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0280-8030 | 0280-8030-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PAMABROM | UA8U0KJM72 | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | OINTMENT / TOPICAL | NA | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e3873745-9bfa-7cd4-e053-2995a90a9892 | 0733f148-0744-4bb3-e054-00144ff8d46c | 2022-07-11 | Warnings | 0733f148-0744-4bb3-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.