Pain Relief PM Nightime Sleep Aid description, usages, side effects, indications, overdosage, supplying and lots more!

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Pain Relief PM Nightime Sleep Aid

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Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients





Purpose

Pain Reliever, Nightime Sleep Aid

Directions: Adults and children 12 years of age and older:
Take 2 tablets at bedtime, do not exceed 2 tablets (50 mg) in 24
hours, or as directed by a doctor. Children under 12 years:
Consult a doctor

Uses

Uses: Temporarily relieves: • occasional headaches with minor
aches and pains • for relief of occasional sleeplessness Temporarily
relieves itchy eyes and runny nose associated with: • common
allergies • hay fever Warnings:

hildren under 12 years of age:
Do not give to children under 12 years of age. Liver Warning: This
product contains acetaminophen. Severe liver damage may occur if
you take: • more than 2 tablets in 24 hours • with other drugs
containing acetaminophen (prescription or nonprescription). Ask a
doctor or pharmacist before using with other drugs if you are not
sure. • 3 or more alcoholic drinks every day while using this product
Caution: This product will cause drowsiness. • do not drive a motor
vehicle or operate machinery after use. • avoid alchoholic
beverages while taking this product • do not take this product if you
are taking sedatives or tranquilizers, without first consulting your
doctor • if sleeplessness persists continuously for more than 2
weeks, consult your doctor. Insomnia may be a symptom of serious
underlying medical illness. Do not use: • more than the
recommended dose • do not take this product unless directed by a
doctor, if you have a breathing problem such as emphysema or
chronic bronchitis, or if you have glaucoma or difficulty in urination
due to enlargement of the prostate glandwith any other product containing
acetaminophen this will provide more than the
recommended dose (overdose) of acetaminophen
and could cause serious health concerns. • with any
other product containing diphenhydramine, even one
used on the skin • for more than 10 days for pain unless
directed by a doctor • for more than 3 days for fever unless
directed by a doctor. • when using this product do not exceed
recommended dose. Stop use and ask a doctor if:
• symptoms do not improve within 7 days or are accompanied by
a fever • pain or fever persists or gets worse • new symptoms
occur • redness or swelling is present • nervousness, dizziness or
sleeplessness occur Ask a doctor before use if you have:
• heart disease • high blood pressure • thyroid disease • diabetes
• difficulty in urination due to enlargement of the prostate gland




If pregnant or breast-feeding baby, ask a health professional
before use.

KEEP OUT OF REACH OF CHILDREN.

Inactive Ingredients: corn starch, FDC Blue 1, maltodextrin,
microcrystalline cellulose, polyethylene glycol, povidone, sodium
starch glycolate, and stearic acid

MM1

Pain Relief PM Nightime Sleep Aid

Pain Relief PM Nightime Sleep Aid

Acetaminophen,Diphenhydramine HCl TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52904-445
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
POVIDONE K30
STEARIC ACID
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
blue (sky blue) 12 mm S ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52904-445-02 2 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2012-10-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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