CAREALL ACETAMINOPHEN- 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

Acetaminophen 325mg

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 immediately (1-800-222-1222).  Quick medical attention is critical for adults as well as for chidren even if you do not notice any signs or symptoms.

Uses

Temporary relieves minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis, premenstrual and menstrual cramps. 

Temporarily reduces fever

WARNINGS

Liver warning: This product contains acetaminophen.  The maximum daily dose of this product is 10 tablets (3,250mg) in 24 hours for adults or 5 tablets (1,625mg) in 24 hours for children.  Severe liver damage may occur if:

Adult takes more than 4,000mg of acetaminphen in 24 hours

Child takes more than 5 doses in 24 hours, which is the maximum daily amount

Taken with other drugs containing acetaminophen

Adult has 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 or 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 user has:

liver disease

is a child with pain of arthritis

Ask a doctor or pharmacist before use if:the user is taking the blood thinnig drug warfarin.

Stop use and ask a doctor if:

Adult's pain gets worse or lasts for more than 10 days. 

Child's pain gets worse or lasts more than 5 days.

Fever gets worse or lasts for more than 3 days. 

Redness or swelling is present.

New symptoms occur. 

These could be signs of a serious condition.

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

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DOSAGE & ADMINISTRATION

Adults and children 12 years and over: 

Take 2 tablets every 4 to 6 hours while symptoms last

Do not take more than 10 tablets in 24 hours, unless directed by a doctor.

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

Children 6-11 years:

Take 1 tablet every 4 to 6 hours while symptoms last. 

Do not take more than 5 tablets in 24 hours, unless directed by a doctor.

Do not use for more than 5 days unless directed by a doctor

Children under 6 years of age: Ask a doctor

INACTIVE INGREDIENT

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-085
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 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	2 pieces
Shape	ROUND (Round Circle)	Size	10mm
Flavor		Imprint Code	M2A3;57344
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-085-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	03/18/2021

Labeler - New World Imports, Inc (075372276)