Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 423a8445-964c-4cdb-889a-f391ca5253e7
Route
ORAL
Published
Effective Date 2018-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Blue No. 1 Hypromelloses Microcrystalline Cellulose Polyethylene Glycol 1000 Povidone Starch, Corn Silicon Dioxide Stearic Acid Titanium Dioxide Carnauba Wax Fd&c Blue No. 2 Polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: G651 Shape: capsule Color: blue Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-23

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime sleep aid


Medication Information

Purpose

Pain reliever

Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

 

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose,

polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

May contain: carnauba wax, FD&C blue #2 aluminum lake, polysorbate 80

Uses

temporarily 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 4000 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.



Directions
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours 
  • 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
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.

  • You may report side effects to 1-888-952-0050
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredients (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 If You Are
  • taking the blood thinning drug warfarin  
  • taking sedatives or tranquilizers
Package/label Principal Display Panel

Pain Relief Label
Pain Relief


Structured Label Content

 

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose,

polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

May contain: carnauba wax, FD&C blue #2 aluminum lake, polysorbate 80

Uses

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

Purpose

Pain reliever

Nighttime sleep aid

Warnings

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

  • more than 4000 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.



Directions
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours 
  • children under 12 years: do not use
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
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.

  • You may report side effects to 1-888-952-0050
Keep Out of Reach of Children (Keep out of reach of children)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredients (in Each Caplet) (Active ingredients (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 If You Are (Ask a doctor or pharmacist if you are)
  • taking the blood thinning drug warfarin  
  • taking sedatives or tranquilizers
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Pain Relief Label
Pain Relief


Advanced Ingredient Data


Raw Label Data

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