ACETAMINOPHEN , ASPIRIN AND CAFFEINE- acetaminophen , aspirin and caffeine capsule

Acetaminophen , Aspirin and Caffeine by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each geltab)

Acetaminophen 250 mg
Aspirin 250 mg

Caffeine 65 mg

PURPOSE

Purposes

Pain reliever

Pain reliever

Pain reliever aid

INDICATIONS & USAGE

Uses

Temporarily relieves minor aches and pains due to:
headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps

WARNINGS

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these
symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Acetaminophen may cause skin reactions.Symptoms may include: skin reddening blisters rash
If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 geltabs in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDS (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasional rapid heartbeat.

DO NOT USE

Do not use

if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

ASK DOCTOR

Ask a doctor before use if

you have liver disease

stomach bleeding warning applies to you

you have a history of stomach problems such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you are taking a diuretic

you have asthma

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking
a prescription drug for diabetes, gout, or arthritis
any other drug, or are under a doctor's care for any serious condition

STOP USE

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better
ringing in the ears or loss of hearing occurs
painful area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
any new symptoms occur
These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 use more than directed (see overdose warning)
drink a full glass of water with each dose
adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours
children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

store at room temperature between 20-25°C(68-77°F)
avoid excessive heat, cold and humidity

INACTIVE INGREDIENT

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized potato starch, purified water, pvpk-30, sorbitol sorbitan solution, stearic acid, talc, titanium dioxide, triacetin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN , ASPIRIN AND CAFFEINE 
acetaminophen , aspirin and caffeine capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0709
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SHELLAC (UNII: 46N107B71O)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
STARCH, POTATO (UNII: 8I089SAH3T)
GLYCERIN (UNII: PDC6A3C0OX)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	green (Dark green - white)	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0709-1	1500 in 1 BAG; Type 0: Not a Combination Product	01/10/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/08/2026

Labeler - Softgel Healthcare Pvt Ltd (676666501)