pain relief pm - extra strength

pain relief pm - extra strength
SPL v3
SPL
SPL Set ID 9238598b-1202-921f-e053-2995a90a019f
Route
oral
Published
Effective Date 2018-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg) acetaminophen (500 mg)
Inactive Ingredients
croscarmellose polyethylene glycol 400 povidone fd&c blue no. 1 microcrystalline cellulose silicon dioxide hypromelloses magnesium stearate starch, corn talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AD01 Shape: capsule Color: blue Size: 18 mm Score: 1
Marketing Status
otc monograph not final active Since 2018-12-20

Description

Acetaminophen 500mg; Diphenhydramine 25mg


Medication Information

Warnings and Precautions

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000mg 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 non prescription). 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 youhave ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostrate gland
  • glaucoma

Ask a doctor or a pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • avoi 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
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

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

Active Ingredient

Acetaminophen 500mg; Diphenhydramine 25mg

Indications and Usage

*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness

Dosage and Administration
  • take with a full glass of water
  • do not take more than directed
  • do not take more than 2 caplets in 24 hours
adults and children 12 years of age and over
  • 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours
children under 12 years of age do not use

Description

Acetaminophen 500mg; Diphenhydramine 25mg

Section 50565-1

Keep out of reach of children

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

Section 51727-6

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Section 51945-4

Section 55105-1

Pain reliever

Nighttime sleep-aid

Section 60561-8
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)

Structured Label Content

Warnings and Precautions (34071-1)

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000mg 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 non prescription). 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 youhave ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostrate gland
  • glaucoma

Ask a doctor or a pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • avoi 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
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

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

Active Ingredient (55106-9)

Acetaminophen 500mg; Diphenhydramine 25mg

Indications and Usage (34067-9)

*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness

Dosage and Administration (34068-7)
  • take with a full glass of water
  • do not take more than directed
  • do not take more than 2 caplets in 24 hours
adults and children 12 years of age and over
  • 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours
children under 12 years of age do not use

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 51727-6 (51727-6)

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever

Nighttime sleep-aid

Section 60561-8 (60561-8)
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)

Advanced Ingredient Data


Raw Label Data

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