![CHILDRENS COUGH AND COLD LIQUID [KINGSTON PHARMA LLC]](https://medic.hrt.org//dailymed/images/df3e9800-72c8-4f3a-a25c-89971684ed99/label.jpg)
| NDC | 71027-047-04 |
| Set ID | df3e9800-72c8-4f3a-a25c-89971684ed99 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | KINGSTON PHARMA LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
-
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
-
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
-
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)
