The following Structured Product Label (SPL) was submitted to the FDA by Health Pharma Usa Llc for the product Acetaminophen 500 Pyrilamine Maleate 15 And Caffeine 60 (NDC 71679-312). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warning, do not use, ask a doctor before use if you have, ask your doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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