Indications and uses
Uses: ■ for the temporary relief of these symptoms associated with menstrual periods: ■ cramps ■ bloating ■ water-weight gain ■ headache ■ backache ■ muscle aches ■ fatigue
Uses: ■ for the temporary relief of these symptoms associated with menstrual periods: ■ cramps ■ bloating ■ water-weight gain ■ headache ■ backache ■ muscle aches ■ fatigue
Directions ■ do not exceed recommended dosage. ■ adults and children 12 years and over: take 2 tablets with water. Repeat every 6 hours, as needed do not exceed 6 tablets per day ■ children under 12 years: consult a doctor
Active ingredient (in each caplet) Purpose
Acetaminophen 500mg..............Pain reliever/Fever reduce
Caffeine 60 mg.............................................................Diuretic
Pyrilamine maleate 15 mg....................................Antihistamine
Pain reliever/Fever reduce
Diuretic
Antihistamine
Uses:
■ for the temporary relief of these symptoms
associated with menstrual periods: ■ cramps
■ bloating ■ water-weight gain ■ headache
■ backache ■ muscle aches ■ fatigue
Warnings
Liver warning: This product contains acetaminophen. Severe
liver damage may occur if you take: ■ more than 6 tablets 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 warning: 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 ■ glaucoma ■ difficulty in urination due to
enlargement of the prostate gland ■ a breathing problem such
as emphysema or chronic bronchitis
ask your doctor or pharmacist before use if you are■■ taking the blood thinning drug warfarin ■ taking sedatives or
tranquilizers When using this product ■ you may get drowsy
■ avoid alcoholic drinks ■ excitability may occur, especially in
children ■ alcohol, sedatives, and tranquilizers may increase
drowsiness ■ be careful when driving a motor vehicle or
operating machinery ■ limit the use of caffeine-containing
medications, foods, or beverages because too much caffeine
may cause nervousness, irritability, sleeplessness, and,
occasionally, rapid heartbeat. The recommended dose of this
product contains about as much caffeine as a cup of coffee.
Stop use and ask a doctor if ■ new symptoms appear ■
redness or swelling is present ■ pain gets worse or lasts for
more than 10 days ■ fever gets worse or lasts for 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
(1-800-222-1222) right away. Quick medical attention is critical
for adults as well as for children even if you do not notice any
signs or symptoms.
When using this product■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery, this
product will cause drowsiness
Stop use and ask a doctor if:■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be
a symptom of serious underlying medical illness. ■ pain gets worse or lasts more than 10 days ■ fever gets
worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur.
These could be signs of a serious condition.
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 (1-800-222-1222) right away.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs
or symptoms.
Directions
■ do not exceed recommended dosage. ■ adults and
children 12 years and over: take 2 tablets with water. Repeat
every 6 hours, as needed do not exceed 6 tablets per day
■ children under 12 years: consult a doctor
Other Information
■ Store at controlled room temperature 20°-25°C (68°-77°F).
■ Read all product information before use.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive ingredients:Colloidal Silicon Dioxide, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Purified Water, Stearic Acid Powder, Talc, Titanium Dioxide.
Questions or comments?
Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71679-312 | 71679-312-00, 71679-312-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| ACETAMINOPHEN | 362O9ITL9D | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| WATER | 059QF0KO0R | IACT |
| TALC | 7SEV7J4R1U | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
| PYRILAMINE MALEATE | R35D29L3ZA | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60 | ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETS | Health Pharma USA LLC | 34eb8a9b-d0ee-13e8-e063-6294a90a2fef | 2026-07-08 | Warnings | 71679-312-20 71679-312-00 71679-312 71679031220 71679031200 56138f15-d8ff-eff5-e063-6394a90a326a 34eb8a9b-d0ee-13e8-e063-6294a90a2fef |