HEADACHE RELIEF PM- acetaminophen, aspirin, diphenhydramine citrate 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), DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

DOLGENCORP, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Pain reliever Nighttime sleep-aid for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Authorization status:

OTC monograph not final

Summary of Product characteristics

HEADACHE RELIEF PM- ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE
CITRATE TABLET, FILM COATED
DOLGENCORP, LLC
_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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DOLLAR GENERAL 44-674
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Diphenhydramine citrate 38 mg
*nonsteroidal anti-inflammatory drug
_PURPOSE_
Pain reliever
Pain reliever
Nighttime sleep-aid
_USES_
for the temporary relief of occasional headaches and minor aches and
pains with
accompanying sleeplessness
_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:
hives
shock
facial swelling
asthma (wheezing)
ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
blisters
rash
skin reddening
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
3 or more alcoholic drinks every day while using this product
with other drugs containing acetaminophen
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 3 or more alcoholic drinks every day while using this product
have had stomach ulcers or bleeding problems
take other drugs containing prescription or nonprescription NSAIDs
[aspirin,
ibuprofen, naproxen, or others]
take more or for a longer time than directed
take a blood thinning (anticoagulant) or steroid drug
DO NOT USE
if you hav