Coricidin Hbp Tablet, Film Coated
FDA Label NDC 71205-312

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Coricidin Hbp (NDC 71205-312). 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 other, otc - purpose, uses, liver warning, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients
(in each tablet)		Purpose

Acetaminophen 325 mg

Pain reliever/ fever reducer

Chlorpheniramine maleate 2 mg

Antihistamine

Uses

  • temporarily relieves
    • minor aches and pains
    • headache
    • sneezing
    • runny nose
    • temporarily reduces fever

Liver Warning

This product contains acetaminophen. Sever liver damage may occur if

  • adult takes more than 12 tablets in 24 hours
  • child takes more than 5 tablets in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product.

Otc - Do Not Use

Do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Otc - Ask Doctor

Ask a doctor before use if the user has

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the user is

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

When Using This Product

  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed (see overdose warning)

    • Adults and children 12 years and over

    2 tablets every 4 to 6 hours, not more than 12 tablets in 24 hours

    Children 6 to under 12 years of age

    1 tablet every 4 to 6 hours, not more than 5 tablets in 24 hours

    Children under 6 years of age

    ask a doctor

Other Information

  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

corn starch, FD&C red No. 40 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Questions Or Comments?

Call 1-800-317-2165

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