pain reliever pm

pain reliever pm
SPL v4
SPL
SPL Set ID 9d2275c8-0c3d-d2b3-e053-2995a90a368e
Route
oral
Published
Effective Date 2020-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg) diphenhydramine (25 mg)
Inactive Ingredients
carnauba wax silicon dioxide croscarmellose sodium fd&c blue no. 1 aluminum oxide fd&c blue no. 2 hypromellose, unspecified microcrystalline cellulose polyethylene glycol, unspecified povidone stearic acid titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G651 Shape: capsule Color: blue Size: 18 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-01-24

Purpose

Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg


Medication Information

Warnings

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

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

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

  • 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
  • skin reddening 
  • blisters
  •  rash
Uses

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

Purpose

Nighttime sleep aid

Directions
  • do not take more than directed (see overdose warning)
  • take 2 caplets at bedtime; do not take more than 2 caplets of this product in 24 hours adults and children 12 years and over: 
  • do not use children under 12 years:
Other Information
  • store between 20º to 25ºC (68º to 77º F)
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, pregelatinized starch, stearic acid, titanium dioxide.

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Questions?

call toll-free 1-800-935-6737

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
Package Labeling:

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.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Overdose warning:

Active Ingredient (in Each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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 prostate gland 
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Warnings

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

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

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

  • 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
  • skin reddening 
  • blisters
  •  rash
Uses

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

Purpose

Nighttime sleep aid

Directions
  • do not take more than directed (see overdose warning)
  • take 2 caplets at bedtime; do not take more than 2 caplets of this product in 24 hours adults and children 12 years and over: 
  • do not use children under 12 years:
Other Information (Other information)
  • store between 20º to 25ºC (68º to 77º F)
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, pregelatinized starch, stearic acid, titanium dioxide.

Questions?

call toll-free 1-800-935-6737

Do Not Use (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
Package Labeling:

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Overdose warning:

Active Ingredient (in Each caplet) (Active ingredient (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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 prostate gland 
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)