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

In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or problems.

Uses

Temporary relief of minor aches and pains associated with:

common cold, headache, toothache, muscular aches, backache, arthritis, premenstrual and menstrual cramps, and reduction of fever

WARNINGS

Liver warning: This product contains acetaminophen.  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

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 allergic to acetaminophen.

Ask a doctor before use if user has: liver disease

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

Stop use and ask a doctor if: Symptoms do not improve.  Pain gets worse or lasts for more than 10 days.  Pain gets worse or lasts more than 5 days in children under 12 years.  Fever gets worse or lasts for more than 3 days.  New symptoms occur.  Redness or swelling is present.  A rare sensitivity reaction occurs. You may report side effects to 1-888-952-0050

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

Overdose warning: taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical action is critical for adults as well as for children, even if you do not notice any signs or symptoms.
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DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours as needed.  Do not take more than 10 tablets in 24 hours.

Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.  Do not take more than 5 tablets in 24 hours.

Children under 6 years of age: Do not use.

INACTIVE INGREDIENT

Corn starch, 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: 51824-061
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 potato (UNII: 5856J3G2A2)

Product Characteristics
Color	white (white )	Score	no score
Shape	ROUND (Round Circle)	Size	11mm
Flavor		Imprint Code	AZ;010
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-061-02	24 in 1 CASE	04/15/2016
1	NDC: 51824-061-01	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 not final	part343	04/15/2016

Labeler - New World Imports, Inc (075372276)