ONLY FOR BODY PAIN- acetaminophen, diphenhydramine hcl tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

O4 Global Trading Usa, Llc

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

ONLY FOR BODY PAIN- ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET
O4 GLOBAL TRADING USA, 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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_ONLY FOR_ - BODY PAIN
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH CAPLET)_
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
_PURPOSE_
Pain reliever
Nighttime sleep aid
_USES:_
temporary relief of occasional headaches and minor aches and pains
with accompanying
sleeplessness
_WARNINGS:_
LIVER WARNING:
This product contains acetaminophen. Severe liver damage may occur if
you take:
more than 1,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks everyday while using this product
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.
DO NOT USE
with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on
skin
in children under 12 years of age
if you have ever had any allergic reaction to this product or any of
its ingredients
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
• liver disease • a breathing problem such as emphysema or chronic
bronchitis
• trouble urinating due to an enlarged prostate gland • glaucoma
ASK A DOCTOR BEFORE USE IF YOU ARE
• taking the blood thinning drug warfarin • taking sedatives or
tranquilizers
WHEN USING THIS PRODUCT
• drowsiness will occur • avoid alcoholic drinks • do not drive
a motor vehicle or operate machinery
STOP USE AND ASK A DOCTOR IF
• sleeplessness persists continously for more than 2 weeks. In