CAREALL ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet

CareALL Acetaminophen by

Drug Labeling and Warnings

CareALL Acetaminophen by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acteminophen 500 mg

PURPOSE

Pain reliever / Fever reducer

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.  ​

INDICATIONS & USAGE

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

Temporarily reduces fever

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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.

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 exceed recommended dosage.

DOSAGE & ADMINISTRATION

​Do not use more than directed (see overdose warnings)

Adults and children 12 years of age and older:

• Take 2 caplets every 6 hours while symptoms last.  
• Do not take more than 6 caplets 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: consult a doctor

INACTIVE INGREDIENT

Corn Starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-099
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
Stearic Acid (UNII: 4ELV7Z65AP)
Povidone (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white (White)	Score	no score
Shape	OVAL (Oval)	Size	18mm
Flavor		Imprint Code	AZ;328
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-099-24	24 in 1 CASE	11/28/2023
1	NDC: 51824-099-01	100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	11/28/2023

Labeler - New World Imports, Inc (075372276)