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Pain Relief Extra Strength Easy to Swallow

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Allegiant Health
NDC Code: 69168-353

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.

Drug Facts

Active ingredient

Acetaminophen 500 mg

Purpose

Analgesic/Antipyretic

Uses

temporary relief of minor aches and pains associated with common cold headache toothache
muscular aches backache arthritis menstrual cramps and reduction of fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

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 or breast-feeding

ask a health professional before use

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.

Directions

Adults and children 12 years of age and older: Take 2 tablets (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor.

Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Inactive Ingredients

carnauba wax, FD&C red #40 aluminum lake, hypromellose, polyethylene glycol(PEG) 400, polyethylene glycol (PEG) 8000, povidone, pregelatinized starch, stearic acid, sucralose, titanium dioxide.

Package/Label Principal Display Panel
PAIN RELIEF  EXTRA STRENGTH EASY TO SWALLOW
acetaminophen 500 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-353
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
FD&C RED NO. 40 
ALUMINUM OXIDE 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 400 
POVIDONES 
STARCH, CORN 
STEARIC ACID 
SUCRALOSE 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize12mm
FlavorImprint CodeTCL342
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-353-2424 TABLET in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/17/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-353), LABEL(69168-353), MANUFACTURE(69168-353), PACK(69168-353), RELABEL(69168-353), REPACK(69168-353)

 
Allegiant Health

Medically reviewed on Dec 18, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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