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  5. Label Information: Coricidin Hbp Cold And Flu

FDA Label for Coricidin Hbp Cold And Flu

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL - 10 TABLET CARTON

Coricidin Hbp Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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