ACETAMAX- acetaminophen 500 mg tablet, effervescent

AcetaMax by

Drug Labeling and Warnings

AcetaMax by is a Otc medication manufactured, distributed, or labeled by Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals, S.P.M CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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INGREDIENTS AND APPEARANCE

ACETAMAX 
acetaminophen 500 mg tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13411-854
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
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
Color	white	Score	no score
Shape	ROUND	Size	22mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13411-854-16	16 in 1 BOX	08/31/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 13411-854-20	20 in 1 BOX	08/31/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 13411-854-24	24 in 1 BOX	08/31/2020
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/31/2020

Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)

Establishment
Name	Address	ID/FEI	Business Operations
S.P.M CORPORATION		555279715	manufacture(13411-854)