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Non-Aspirin Acetaminophen

Medically reviewed on February 6, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Redicare LLC
NDC Code: 71105-210

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Acetaminophen (non-aspirin)

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

NON-ASPIRIN ACETAMINOPHEN 
non-aspirin acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint CodeFR1
Contains    
Packaging
#Item CodePackage Description
1NDC:71105-210-68100 TABLET in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/01/2017
Labeler - Redicare LLC (800149346)
Establishment
NameAddressID/FEIOperations
Redicare LLC800149346repack(71105-210)

 
Redicare LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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