Acetaminophen 500mg Pyrilamine Maleate 15mg and Caffeine 60mg Tablets

Manufacturer
Health Pharma USA LLC
Effective date
2026-07-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
weekly-update
Hydrated at
2026-07-17 21:43:50

Label at a glance#

ProductAcetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60
Active ingredientCAFFEINE, PYRILAMINE MALEATE
Label structure15 sections

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet) Purpose

Acetaminophen 500mg..............Pain reliever/Fever reduce
Caffeine 60 mg.............................................................Diuretic
Pyrilamine maleate 15 mg....................................Antihistamine

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reduce
Diuretic
Antihistamine

Uses

INDICATIONS & USAGE SECTION

Uses:
■ for the temporary relief of these symptoms
associated with menstrual periods: ■ cramps
■ bloating ■ water-weight gain ■ headache
■ backache ■ muscle aches ■ fatigue

Warning

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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 doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Questions or comments?
Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

71679-312-00-Bulk Label71679-312-00-Bulk Label

71679-312-20-Midol Complete-20s- Peel off Label-100cc71679-312-20-Midol Complete-20s- Peel off Label-100cc

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71679-31271679-312-00, 71679-312-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
ndc (package): 71679-312-20
ndc (package): 71679-312-00
ndc (product): 71679-312
ndc11 (package): 71679031220
ndc11 (package): 71679031200
spl id: 56138f15-d8ff-eff5-e063-6394a90a326a
spl set id: 34eb8a9b-d0ee-13e8-e063-6294a90a2fef