acetamax Pm

 acetamax Pm
SPL v1
SPL
SPL Set ID 843123f9-480d-4e56-b639-fd345a49c7ab
Route
ORAL
Published
Effective Date 2020-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Anhydrous Citric Acid Dimethicone Mannitol Polyethylene Glycol 6000 Polysorbate 20 Povidone K30 Silicon Dioxide Sodium Bicarbonate Sodium Carbonate Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-31

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Fever Reducer/Pain Reliever Nighttime sleep aid


Medication Information

Purpose
  • Fever Reducer/Pain Reliever
  • Nighttime sleep aid
Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

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

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.

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)

Active Ingredients

Acetaminophen 500 mg



Diphenhydramine HCl 25 mg

Inactive Ingredients

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


Structured Label Content

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

Purpose
  • Fever Reducer/Pain Reliever
  • Nighttime sleep aid
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.

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 (Other information)



Each tablet contains:

Sodium 192 mg

Store at room temperature 68 F-77 F (20oC-25oC)

Active Ingredients

Acetaminophen 500 mg



Diphenhydramine HCl 25 mg

Inactive Ingredients

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


Advanced Ingredient Data


Raw Label Data

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