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Pediacare® Children's Cough and Cold Grape


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - PURPOSE SECTION

Brompheniramine maleate, USP 2 mgAntihistamine
Dextromethorphan HBr, USP 10 mgCough Suppressant
Phenylephrine HCl, USP 5 mgNasal decongestant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nosesneezingitchy, watery eyesitching of the nose or throat
  • temporarily restores freer breathing through the nose

Warnings


Do not use

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certaindrugs 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.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

  • taking any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, 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.


Directions

adults and children 12 years and over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosing cup with product
  • mL = milliliter

Other information

  • store at 20-25°C (68-77°F)

Inactive ingredients

citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose


SPL UNCLASSIFIED SECTION

Distributed by CrossingWell Consumer Health PO Box 440 Cornwall, NY 12518