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

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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.  Prompt 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 severe 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:

  • 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 product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have even had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if youhave

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if youare

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

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 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.  

PMC50024 Label

CAREALL NON-ASPIRIN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-059
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 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULE (Capsual Shaped) Size16mm
FlavorImprint Code AZ267;G651
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-059-5050 in 1 BOTTLE; Type 0: Not a Combination Product10/14/202007/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01305/01/201707/01/2023
Labeler - New World Imports, Inc (075372276)

Revised: 1/2024
 
New World Imports, Inc