HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin, caffeine tablet, film coated

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)

Available from:

L.N.K. International, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 250 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Pain reliever Pain reliever aid  - temporarily relieves minor aches and pains due to: a cold  headache arthritis muscular aches toothache premenstrual and menstrual cramps - a cold  - headache - arthritis - muscular aches - toothache - premenstrual and menstrual cramps

Authorization status:

OTC monograph not final

Summary of Product characteristics

HEADACHE RELIEF EXTRA STRENGTH- ACETAMINOPHEN, ASPIRIN, CAFFEINE
TABLET,
FILM COATED
L.N.K. INTERNATIONAL, 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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SOUND BODY 44-334B-DELISTED
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
_PURPOSE_
Pain reliever
Pain reliever
Pain reliever aid
_USES_
temporarily relieves minor aches and pains due to:
a cold
headache
arthritis
muscular aches
toothache
premenstrual and 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: Aspirin may cause a severe allergic reaction, which may
include:
shock
facial swelling
hives
asthma (wheezing)
ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
skin reddening
blisters
rash
If a skin reaction occurs, stop use and seek medical help right away.
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
you take
more than 4,000 mg of acetaminophen in 24 hours
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
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
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take more or for a longer time than di