ACETAMINOPHEN, ASPIRIN, AND CAFFEINE tablet

Acetaminophen, Aspirin, and Caffeine by

Drug Labeling and Warnings

Acetaminophen, Aspirin, and Caffeine by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each geltab)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)**

Caffeine 65 mg

**nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Uses

Temporarily relieves minor aches and pains due to:

headache

 a cold

 arthritis

 muscular aches

 toothache

premenstrual & menstrual cramps

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

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.

If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin at 20 weeks or later in 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.

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 children even if you do not notice any signs or symptoms.

Directions

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

Other information

• store at 20°-25°C(68°-77°F)
• close cap tightly after use
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, PVPK-30, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Questions?

call toll-free 1-844-912-4012

PRINCIPAL DISPLAY PANEL-100 Count

NDC: 37835-531-01

Compare to the active ingredients in Excedrin® Extra Strength*

Extra Strength

Acetaminophen, Aspirin (NSAID)**, and Caffeine

Pain Reliever/ Pain Reliever Aid

100 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

Distributed by:

BI-MART

Eugene, OR 97402

PRINCIPAL DISPLAY PANEL-250 Count

NDC: 37835-531-25

Compare to the active ingredients in Excedrin® Extra Strength*

Extra Strength

Acetaminophen, Aspirin (NSAID)**, and Caffeine

Pain Reliever/ Pain Reliever Aid

250 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.

Distributed by:

BI-MART

Eugene, OR 97402

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN, ASPIRIN, AND CAFFEINE 
acetaminophen, aspirin, and caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-531
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	HH6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-531-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2025
2	NDC: 37835-531-25	250 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/01/2025

Labeler - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
Health Pharma USA LLC		080804485	manufacture(37835-531)