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

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid


Medication Information

Purpose

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

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
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:
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
Questions?

call toll-free 1-800-935-6737

Other Information
  • store between 20º to 25ºC (68º to 77º F)
Package Labeling:

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.

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

Uses

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

Purpose

Nighttime sleep aid

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
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:
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
Questions?

call toll-free 1-800-935-6737

Other Information (Other information)
  • store between 20º to 25ºC (68º to 77º F)
Package Labeling:

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.

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

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