CAREALL ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet 
New World Imports, Inc

----------

Drug Facts

Active Ingredient

Acteminophen 500 mg

Purpose

Pain reliever / Fever reducer

Keep out of reach of Children

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you don't notice any signs or symptoms.

Uses

For the temporary of minor aches and pains associated with: common cold, headache, toothache, muscular  aches, backache, arthritis, premenstrual and menstrual cramps

Temporarily reduces fever.

Warnings

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

-Adults take more than 4,000mg 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:

-If you are allergic to Acetaminophen

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

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if:

-Symptoms do not improve

-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

-A rare sensitivity reaction occurs

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

Do not use more than directed (see overdose warning)  

Adults and children 12 years of age and older: Take 2 tablets every 6 hours as needed.  Do not take more than 6 tablets in 24 hours, unless directed by a doctor.

Do not take for more than 10 days unless directed by a doctor.

Children under 12 years of age: consult a doctor

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

APAP label
CAREALL ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
Starch, Corn (UNII: O8232NY3SJ)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Povidone (UNII: FZ989GH94E)  
Sodium starch glycolate Type A potato (UNII: 5856J3G2A2)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeROUND (round) Size12mm
FlavorImprint Code AZ;011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-060-0224 in 1 CASE04/15/2016
1NDC:51824-060-01100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01304/15/2016
Labeler - New World Imports, Inc (075372276)

Revised: 12/2023
Document Id: e2ed9cbc-d8aa-429a-88ff-921c37a84c2d
Set id: 5103450a-3095-49cc-9823-4fb4c1d258ff
Version: 3
Effective Time: 20231215
 
New World Imports, Inc