NON-ASPIRIN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet 
New World Imports, 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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Drug Facts

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Pain Reliever / Fever Reducer

Sleep Aid

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.

Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

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.

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.

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

label

NON-ASPIRIN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-267
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScoreno score
ShapeCAPSULE (Capsual Shaped) Size18mm
FlavorImprint Code AZ267
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-267-5050 in 1 BOTTLE; Type 0: Not a Combination Product09/01/201208/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/01/201208/01/2020
Labeler - New World Imports, Inc (075372276)

Revised: 8/2017
 
New World Imports, Inc