ACETAMAX PM- acetaminophen,diphenhydramine hcl 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 PM

Active Ingredients

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening

• blisters

• rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
• a sodium-restricted diet.
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma

Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product
• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• These could be signs of a serious condition.

If pregnant or breast-feeding,
ask a health professional before use.


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

Keep out of reach of children.

Directions


Do not take more than directed (see overdose warning)
Adults and children 12 years and over:
• take 2 tablets fully dissolved in 8oz of water at  bedtime.
• do not take more than 2 tablets of this product in 24 hours

Children under 12 years: do not use

Other information


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

Inactive Ingredients

anhydrous citric acid, dimethicone, flavors, mannitol, polyethylene glycol 6000, polysorbate 20, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium citrate, sucralose

Image

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ACETAMAX PM 
acetaminophen,diphenhydramine hcl tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-855
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize22mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13411-855-1616 in 1 BOX08/31/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:13411-855-2020 in 1 BOX08/31/2020
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:13411-855-2424 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(13411-855)

Revised: 8/2020
Document Id: 7e8b1b33-14b9-4c83-ac11-21b24d78e8f5
Set id: 843123f9-480d-4e56-b639-fd345a49c7ab
Version: 1
Effective Time: 20200831
 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals