NON-ASPIRIN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet

Non-Aspirin PM by

Drug Labeling and Warnings

Non-Aspirin PM by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen 500mg

Diphenhydramine HCl 25mg

PURPOSE

Pain Reliever / Fever Reducer

Sleep Aid

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt Medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.

INDICATIONS & USAGE

Temporarily relieves 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 directed
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 products 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
glaucoma
difficulty or urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you:

are taking the blood thinning drug warfarin
are taking sedatives or tanquilizers
When using this product:

drowsiness will occur
do not drive a motor vehicle or operate machinery after use
avoid alcoholic drinks
Stop use and ask a doctor if:

pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
new symptoms occur
redness or swelling is present
sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness

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

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older: Take 2 caplets at bedtime or as directed by a doctor

Children under 12 years of age: Do not use this adult strength product.  This will provide more than the recommended dose (overdose) and could cause serious health problems.

INACTIVE INGREDIENT

Croscarmellose sodium, FD and C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide.  May contain silicon dioxide, sodium starch glycolates

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NON-ASPIRIN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-267
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE (Capsual Shaped)	Size	18mm
Flavor		Imprint Code	AZ267
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-267-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2012	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/01/2012	08/01/2020

Labeler - New World Imports, Inc (075372276)