HEADACHE FORMULA PM- acetaminophen and diphenhydramine citrate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

SUPERVALU INC.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 500 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 FORMULA PM- ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE TABLET,
FILM COATED
SUPERVALU 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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EQUALINE 44-373
_ACTIVE INGREDIENTS (IN EACH TABLET)_
Acetaminophen 500 mg
Diphenhydramine citrate 38 mg
_PURPOSE_
Pain reliever
Nighttime sleep-aid
_USES_
for the 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 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
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
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 OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
avoid alcoholic beverages
be careful when driving a motor vehicle or operating machinery
drowsiness may occur
STOP USE AND ASK A DOCTOR IF
sleeplessness lasts continuously for more than 2 weeks. Insomnia may
be a symptom of a serious
underlying medical illness.
new symptoms occur
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
painful area is red or swollen
These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
OVERDOSE WARNING: Taking more than the recommended dose (overdos