Label: CHILDRENS COUGH AND COLD liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71027-047-04 - Packager: KINGSTON PHARMA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 30, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings:
Do not use:
- 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.
- To make a child sleep.
Ask a doctor before use if you have
- Glaucoma
- Thyroid disease
- High blood pressure
- Heart disease
- Diabetes
- Trouble urinating due to an enlarged prostate gland
- Persistent or chronic cough such as occurs with smoking, asthma or emphysema
- Cough that occurs with too much phlegm (mucus)
- A breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- Taking sedatives or tranquilizers
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WHEN USING
When using this product
- Do not exceed recommended dosage
- Excitability may occur especially in children
- Marked drowsiness may occur
- Avoid alcoholic drinks
- Alcohol, sedatives and tranquilizers may increase drowsiness
- Be careful when driving a motor vehicle or operating machinery
Stop use and ask doctor if
- Nervousness, dizziness or sleeplessness occur
- Symptoms do not get better within 7 days or are accompanied by fever
- Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts
A persistent cough may be a sign of a serious condition
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
Directions:
- Use enclosed dosing cup.
- Do not take more than 6 doses in any 24-hour period.
- Adults and children 12 years and over: take 4 teaspoons or 20 mL every 4-6 hours.
- Children 6 to under 12 years: take 2 teaspoons or 10 mL every 4-6 hours. ask a doctor
- Children 4 to under 6 years: do not use unless directed by a doctor
- Children under 4 years: do not use
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS COUGH AND COLD
childrens cough and cold liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71027-047 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71027-047-04 1 in 1 CARTON 03/01/2017 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2017 Labeler - KINGSTON PHARMA LLC (080386521) Registrant - KINGSTON PHARMA LLC (080386521) Establishment Name Address ID/FEI Business Operations KINGSTON PHARMA LLC 080386521 manufacture(71027-047)
