Valumeds Pain Relief Pm Pain Reliever And Nighttime Sleep Aid Acetaminophen, Extra Strength

Valumeds Pain Relief Pm Pain Reliever And Nighttime Sleep Aid Acetaminophen, Extra Strength
SPL v1
SPL
SPL Set ID 19ba1fb6-22ea-488e-9e52-94c14ceb80d1
Route
ORAL
Published
Effective Date 2024-10-02
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 Lake Fd&c Blue No. 2 Aluminum Lake Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Povidone K30 Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G651 Shape: capsule Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Acetaminophen USP, 500 mg Diphenhydramine HCl USP, 25 mg

Purpose

Pain reliever Nighttime sleep aid


Medication Information

Purpose

Pain reliever

Nighttime sleep aid

Description

Acetaminophen USP, 500 mg Diphenhydramine HCl USP, 25 mg

Uses

temporary 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 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

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
Drug Facts

Other Information
  • store between 20°-25°C (68°-77°F)
  • see bottom of the label for expiration date and lot number
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 80, povidone k-30, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM PST

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

Keep Out of Reach of Children

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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 USP, 500 mg

Diphenhydramine HCl USP, 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

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

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
Drug Facts

Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
  • see bottom of the label for expiration date and lot number
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 80, povidone k-30, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM PST

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

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

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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 USP, 500 mg

Diphenhydramine HCl USP, 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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