Label: CHILDRENS TUSSIN DM liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71027-032-04 - 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 March 1, 2017
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
DO NOT USE IF PRINTED SEAL OVER IS TORN OR MISSING
Warnings:
Do not use if a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
Directions:
- This product does not contain directions or complete warnings for adult use.
- Use only enclosed dosing cup provided.
- Do not take more than 6 doses in any 24-hour period.
- Children 6 years to under 12 years: 5 mL – 10 mL taken every 4 hours.
- Children 4 years to under 6 years: 2.5 mL – 5 mL taken every 4 hours.
- 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 TUSSIN DM
childrens tussin dm liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71027-032 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 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) SUCRALOSE (UNII: 96K6UQ3ZD4) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71027-032-04 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(71027-032)