PAIN FREE- acetaminophen, aspirin, caffeine, salicylamide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC)

Available from:

Afassco Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 110

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever, Stimulant Uses: For the temporary relief of pain from: • headaches • colds • muscular aches • menstrual cramps • toothaches • minor arthritic pain • backaches

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAIN FREE- ACETAMINOPHEN, ASPIRIN, CAFFEINE, SALICYLAMIDE TABLET
AFASSCO INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
Active Ingredients (In Each Tablet)
Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide
152 mg
Pain reliever, Stimulant
Uses: For the temporary relief of pain from:
• headaches • colds • muscular aches
• menstrual cramps • toothaches
• minor arthritic pain • backaches
Warnings:
Reye's Syndrome: Children and teenagers should not use this medicine
for chicken pox or flu symptoms
before a doctor is consulted about Reye's Syndrome, a rare but serious
illness reported to be associated
with aspirin.
Liver Warning: This product contains Acetaminophen. Severe liver
damage may occur if you take more
than 8 tablets in 24 hours, with other drugs containing acetaminophen
(prescription or non-prescription),
or have 3 or more alcoholic drinks every day while using this product.
Stomach Bleeding Warning: This product contains a nonsteroidal
anti-inflammatory drug (NSAID),
which may cause stomach bleeding. The chance is higher if you have had
stomach ulcers or bleeding
problems, take a blood thinning (anticoagulant) or steroid drug, are
age 60 or older, have 3 or more
alcoholic drinks every day while using this product, take with other
drugs containing an NSAID, or take
more or for a longer time than directed.
If pregnant or breast-feeding, ask a health care professional before
use.
Keep out of reach of children.
Directions:
Adults and children: (12 years and older) Take 1 to 2 tablets with a
full glass of water every 4 hours as
needed. Do not exceed 6
tablets in 24 hours, or as directed by doctor.
Children: (under 12 years) Do not give to children under 12 years of
age
SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION
PAIN FREE
acetaminophen, aspirin, caffeine, salicylamide tablet
Afassco Inc.
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