CAREALL NON ASPIRIN EXTRA STRENGTH- acetaminophen tablet

CareALL Non Aspirin by

Drug Labeling and Warnings

CareALL Non Aspirin 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 immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.  ​Do not exceed recommended dosage.

INDICATIONS & USAGE

Temporary relief of minor aches and pains associated with: common cold, headache, toothache, muscular  aches, backache, arthritis, menstrual cramps, and reduction in 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.

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

-You may report side effects to 1-888-952-0050

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 4 to 6 hours as needed.  Do not take more than 8 caplets in 24 hours.  ​Do not use more than 10 days unless directed by a doctor.

Children under 12 years of age: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

INACTIVE INGREDIENT

Corn Starch, Pregelatinized Starch, Stearic Acid.  May contain providone and sodium starch glycolates

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL NON ASPIRIN  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-049
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)
Propylene Glycol (UNII: 6DC9Q167V3)
Stearic Acid (UNII: 4ELV7Z65AP)
Povidone (UNII: FZ989GH94E)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)

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: 51824-049-24	24 in 1 CASE	09/17/2015
1	NDC: 51824-049-01	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	09/17/2015

Labeler - New World Imports, Inc (075372276)