ACETAMAX PM- acetaminophen,diphenhydramine hcl tablet, effervescent

AcetaMax PM by

Drug Labeling and Warnings

AcetaMax PM 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 Ingredients

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

• Fever Reducer/Pain Reliever
• Nighttime sleep aid

Uses

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

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

SPL UNCLASSIFIED SECTION

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INGREDIENTS AND APPEARANCE

ACETAMAX PM 
acetaminophen,diphenhydramine hcl tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13411-855
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
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: 13411-855-16	16 in 1 BOX	08/31/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 13411-855-20	20 in 1 BOX	08/31/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 13411-855-24	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(13411-855)