ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE capsule, liquid filled

Acetaminophen , Caffeine and pyrilamine maleate by

Drug Labeling and Warnings

Acetaminophen , Caffeine and pyrilamine maleate by is a Otc medication manufactured, distributed, or labeled by Softgel Healthcare Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgelatin capsule)

Acetaminophen 500mg
Caffeine 60mg
Pyrilamine maleate 15mg

PURPOSE

purpose

• Pain reliever
• Diuretic
• Antihistamine

INDICATIONS & USAGE

Uses

for the temporary relief of these symptoms associated with menstural periods:

cramps

bloating

waterweight gain

headache

backache

muscle aches

fatigue

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 6 softgel 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: hives blisters rash skin reddening facial swelling asthma (wheezing) shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.

DO NOT USE

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 DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers

WHEN USING

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 beacuse 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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
do not take more than the recommended dose
adults and children 12 years and older: take 2 softgel with water
repeat every 6 hours as needed
do not exceed 6 softgel per day
children under 12 years: consult a doctor

OTHER SAFETY INFORMATION

store at room temperature.

INACTIVE INGREDIENT

Inactive ingredients

croscarmellose sodium, D&C red 33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue 1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, purified water, PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE 
acetaminophen , caffeine and pyrilamine maleate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0710
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C RED NO. 33 ALUMINUM LAKE (UNII: L3FT3LUT29)
STARCH, POTATO (UNII: 8I089SAH3T)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE K30 (UNII: U725QWY32X)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Product Characteristics
Color	blue (Dark blue and light blue)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0710-1	1500 in 1 BAG; Type 0: Not a Combination Product	12/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/12/2025

Labeler - Softgel Healthcare Pvt Ltd (676666501)