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Coricidin HBP Cough and Cold UI 1614831


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet) Purpose

Chlorpheniramine maleate 4 mg………………………….....................Antihistamine

Dextromethorphan hydrobromide 30 mg……………………… .Cough suppressant


INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves runny nose and sneezing due to the common cold

WARNINGS SECTION

Warnings


OTC - DO NOT USE SECTION

Do not use

Do not use to sedate children.

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.


OTC - PREGNANCY OR BREAST FEEDING SECTION

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


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact

a Poison Control Center right away. Abuse of this product can lead to serious injury.


DOSAGE & ADMINISTRATION SECTION

Directions

than 4 tablets in 24 hours

  • do not exceed recommended dose
  • adults and children 12 years and over: take 1 tablet every 6 hours, not more

OTHER SAFETY INFORMATION

Other information

  • store between 20º to 25ºC (68º to 77ºF)
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

Inactive ingredients croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide


OTC - QUESTIONS SECTION

Questions or comments? 1-800-317-2165 (Mon-Fri 9AM - 5PM EST)


HOW SUPPLIED

Product: 50090-5534

NDC: 50090-5534-0 8 TABLET in a BLISTER PACK / 2 in a CARTON


CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE