NIGHTTIME PAIN RELIEVER PLUS SLEEP AID- acetaminophen, diphenhydramine hcl solution

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:

WALMART INC.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

NIGHTTIME PAIN RELIEVER PLUS SLEEP AID- ACETAMINOPHEN,
DIPHENHYDRAMINE HCL SOLUTION
WALMART INC.
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EQUATE 44-074
_ACTIVE INGREDIENTS (IN EACH 30 ML)_
Acetaminophen 1,000 mg
Diphenhydramine HCl 50 mg
_PURPOSE_
Pain reliever
Nighttime sleep-aid
_USE_
for the temporary relief of occasional 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
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 an allergic reaction to this product or any of
its ingredients
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
drowsiness will occur
avoid alcoholic beverages
do not drive a motor vehicle or operate machinery
STOP USE AND ASK A DOCTOR IF
sleeplessness persists continuously for more than 2 weeks. Insomnia
may be a
symptom of a serious underlying medical illness.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
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.
In case of overdose, ge