Acetaminophen And Diphenhydramine Hcl
FDA Label NDC 68151-0703

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carilion Materials Management for the product Acetaminophen And Diphenhydramine Hcl (NDC 68151-0703). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingrdient, purpose, uses, warnings, directions, other information, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingrdient

(in each captab)

Purpose

Pain Reliever/Sleep Aid

Uses

Temporarily relieves 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 8 captabs in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product.

    • 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 drug containing diphenhydramine, even one used on skin
    • in children under 12 years of age

      Ask a doctor before use if you have

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

      Ask a doctor or pharmacist before use if you are.

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

      When using this product

    • marked drowsiness will occur
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • do not drive motor vehicle or operate machinery

      Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear
    • sleeplessness lasts more than 2 weeks. Insomnia may be a sign of serious underlying medical illness.

      If pregnant or breast feeding, ask a health professional before use.

      Keep out of children.

      In case of 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.

Directions

adults and children 12 years or over:

  • take 2 captabs at bedtine if needed
  • do not take more than directed

    • childrens under 12 years do not use

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

Croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide.

Questions

Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday.

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