PM ACETAMINOPHEN  - diphenhydramine and acetaminophen tablet 
New World Imports, Inc

Drug Facts

Acetaminophen 500 mg

Diphenhydramine HCI 25 mg

Acetaminophen - Pain Reliever

Diphenhydramine - Nighttime Sleep Aid

Keep out of reach of Children

Temporary relief of occasional headaches, minor aches, and pains accompanying sleeplessness

Liver Warning:This product contains acetaminophen.  Severe liver damage may occur with this product if you take:

More than 2 caplets in 24 hours, which is the daily maximum amount

With other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Overdose warning: Taking more than the recommended done (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Do not use:

With other products containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

In Children under 12 years of age

With other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have: liver disease, asthma, breathing problems such as emphysema or chronic bronchitis, glaucoma, or difficulty in urinating due to an enlargement of the prostate gland.

Ask a doctor or pharmacist before use if you are: taking sedatives or tranquilzers, or taking the blood thinning drug warfin

When using this product: Avoid alcoholic beverages, do not drive a motor vehicle or operate machinery.  This product will cause drowsiness.

Stop use and ask a doctor if:

Sleepiness persists continuously for more than 2 weeks.  Insomnia may be a symptom of a serious underlying medical illness.

Pain gets worse or last for more than 10 days

Fever gets worse or lasts for more than 3 days

New symptoms occur

Redness or swelling is present

If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children.

Do not exceed recommended dose

Adults and children 12 years of age and over: take 2 caplets at bedtime.  Do not take more than 2 caplets in 24 hours.

Children under 12 years of age:Do not use this product in children under 12 years of age.  This will provide more than the recommended dose (overdose) and may cause liver damage.

FD and C Blue #1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide.


diphenhydramine, acetaminophen  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 51824-015
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine (Diphenhydramine) Diphenhydramine 25 mg
Acetaminophen (Acetaminophen) Acetaminophen 500 mg
Inactive Ingredients
Ingredient Name Strength
Magnesium Stearate  
Cellulose, Microcrystalline  
Polyethylene Glycol  
Polyvinyl Alcohol  
Povidone K30  
Stearic Acid  
Titanium Dioxide  
Product Characteristics
Color blue (Sky Blue) Score no score
Shape OVAL (Oval) Size 18mm
Flavor Imprint Code V15
# NDC Package Description Multilevel Packaging
1 51824-015-05 50 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 09/30/2010

Labeler - New World Imports, Inc (075372276)
Revised: 09/2010New World Imports, Inc