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

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

Uses

Temporary relief of minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, arthritis, premenstrual and menstrual cramps, and 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 or any of the inactive ingredients in this product.

-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:

-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

These could be signs of a serious condition.

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

Do not take more than directed (see overdose warning)  

Adults and children 12 years of age and older:

Take 2 tablets every 6 hours while symptoms last 

Do not take more than 6 tablets in 24 hours, unless directed by a doctor

Do not use more than 10 days unless directed by a doctor

Children under 12 years of age: ask a doctor

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

ACT50024
CAREALL ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-086
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 CORN (UNII: AG9B65PV6B)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeROUND (round) Size12mm
FlavorImprint Code M2A4;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-086-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/18/2021
Labeler - New World Imports, Inc (075372276)

Revised: 11/2023
Document Id: 968b1ad3-11a0-4a70-9457-d67bf33dc350
Set id: f818417e-0b31-4fe7-8313-4160a00b248a
Version: 2
Effective Time: 20231130
 
New World Imports, Inc