ACETAMAX- acetaminophen 500 mg tablet, effervescent 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals

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.

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AcetaMax

Active Ingredient

Acetaminophen 500 mg

Purpose

Pain reliever/ Fever Reducer

Uses

temporarily relieves minor aches and pains due to:
▪ headache
▪ backache
▪ toothache
▪ the common cold
▪ minor pain of arthritis
▪ muscular aches
▪ premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Alcohol warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/ fever reducers.

Acetaminophen may cause liver damage.

Do not use with any other product containing acetaminophen

Ask a doctor before use if you have
• a sodium-restricted diet
• any liver, kidney, or heart disease
• high blood pressure

Ask a doctor or pharmacist before use if you are
• allergic or sensitive to any tablet ingredients
• pregnant, breastfeeding or may become pregnant
When using this product
• do not exceed the recommend dosage

Stop use and ask a doctor if
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days.

If pregnant, may become pregnant, or breastfeeding, ask a health professional before use.

KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center immediately. 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 take more than directed (see overdose warning)

Adults and children 12 years and over
• take two tablets fully dissolved in 8 oz of water every 4 to 6 hours as needed.
• do not take more than 8 tablets in 24 hours.
• do not use more than 10 days unless directed by a doctor.
Children under 12 years do not use this adult product; this will provide more than the dose (overdose) of pain reliever and may cause liver damage.

Other information

Each tablet contains:
Sodium 192 mg.
Store at room temperature 68 F-77 F (20oC-25oC).

Inactive Ingredients

anhydrous citric acid, dimethicone, docusate sodium, flavors, ginger oil, lemongrass oil, mannitol, polyethylene glycol 6000, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium chloride, sodium citrate, sucralose, sucrose.

Image

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ACETAMAX 
acetaminophen 500 mg tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-854
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
GINGER OIL (UNII: SAS9Z1SVUK)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize22mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13411-854-1616 in 1 BOX08/31/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:13411-854-2020 in 1 BOX08/31/2020
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:13411-854-2424 in 1 BOX08/31/2020
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/31/2020
Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)
Establishment
NameAddressID/FEIBusiness Operations
S.P.M CORPORATION555279715manufacture(13411-854)

Revised: 8/2020
Document Id: 711febe5-d7de-4d28-aa18-748bdd881d9f
Set id: ac8606d3-da20-4936-b8b2-75c418847f4f
Version: 1
Effective Time: 20200831
 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals