CAREALL NON-ASPIRIN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet 
New World Imports, Inc

----------

Drug Facts

Active Ingredients

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain reliever

Nightime 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 (1-800-222-1222) right away.  Quick Medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Uses

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 4000 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 sever 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:

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

•drowsiness will occur

•do not drive a motor vehicle or operate machinery

•avoid alcoholic drinks

Stop use and ask a doctor if

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

•pain gets worse or last for more than 10 days.

•fever gets worse or last for more than 3 days

•redness or swelling are present

•new symptoms occur.  These could be signs of a serious condition.

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

Directions

Do not use more than directed.  (see overdose warning)

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

Children under 12 years: do not use

Inactive Ingredients

Croscarmellose sodium, FD and C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide, Copovidone K25-31, Lactose, and Magnesium Sterate

PMC50024 Label
CAREALL NON-ASPIRIN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-069
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)  
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)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize17mm
FlavorImprint Code AAA;1031
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-069-5050 in 1 BOTTLE; Type 0: Not a Combination Product11/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/30/2018
Labeler - New World Imports, Inc (075372276)

Revised: 11/2023
Document Id: 8b8fb595-7289-4e3d-82b5-352a3fa28f80
Set id: 499b2bf8-72fb-4500-b16e-517cab09a8ae
Version: 3
Effective Time: 20231130
 
New World Imports, Inc