PAIN RELIEF EXTRA STRENGTH- acetaminophen 500 mg tablet 
Allegiant Health

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Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporary relief of minor aches and pains associated with   ■ the common cold   ■ headache    ■  toothache   ■ muscular aches   ■ backache     ■ minor pain from arthritis  

■ premenstrual  and menstrual cramps   ■ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take n more than 4,000mg
of acetaminophen in 24 hours

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present.

These could be signs of a serious condition

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

■ do not use more than directed (see Overdose warning)  

Adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last

Do not take more than 6 caplets in 24 hours, unless directed by a doctor  

Do not use more than 10 days unless directed by a doctor  

Children under 12 years: Consult a doctor

Other information

■ store between 20º-25ºC (68º-77ºF)
■ do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or Comments

Call 1-888-952-0050 Monday to Friday 9am-5pm EST

Package/Label Principal Display Panel

Health A2Z®

Compare to Tylenol® active ingredient*

See New Warnings Information

Extra Strength
PAIN RELIEF
Acetaminophen
Pain Reliever-Fever Reducer
CONTAINS NO ASPIRIN

500 mg
Pain Relief

Pain Relief

PAIN RELIEF  EXTRA STRENGTH
acetaminophen 500 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-328
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code AZ328
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-328-4040 in 1 CARTON; Type 0: Not a Combination Product12/17/2014
2NDC:69168-328-01100 in 1 CARTON; Type 0: Not a Combination Product12/17/2014
3NDC:69168-328-13175 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2014
4NDC:69168-328-03250 in 1 BOTTLE; Type 0: Not a Combination Product12/17/201405/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/17/2014
Labeler - Allegiant Health (079501930)
Establishment
NameAddressID/FEIBusiness Operations
Allegiant Health079501930analysis(69168-328) , label(69168-328) , manufacture(69168-328) , pack(69168-328)

Revised: 3/2020
Document Id: 7ed5b51e-f50e-42cd-965e-2962d68ec75f
Set id: 8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7
Version: 10
Effective Time: 20200313
 
Allegiant Health