NON-ASPIRIN ACETAMINOPHEN tablet

Non-Aspirin Acetaminophen by

Drug Labeling and Warnings

Non-Aspirin Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Redicare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet) ..................................................... Purpose

Acetaminophen 500 mg .....................................................................................pain reliever/fever reducer

Uses:

temporarily relieves minor aches and pains associated with ■ a headache ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache

Warnings:

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.

Do not use:

■ with any other product containing acetaminophen ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor

When using this product do not exceed recommended dose.

Stop use and ask a doctor if

■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present

If pregnant or breast-feeding a baby,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

In a case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Adults and children 12 years of age or older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor
Children under 12 years of age: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

Other Information:

■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) Avoid excessive heat and humidity

Inactive Ingredients:

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NON-ASPIRIN ACETAMINOPHEN 
non-aspirin acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71105-210
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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71105-210-68	100 in 1 CARTON; Type 0: Not a Combination Product	10/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/01/2017

Labeler - Redicare LLC (800149346)

Establishment
Name	Address	ID/FEI	Business Operations
Redicare LLC		800149346	repack(71105-210)