Label: TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR- dextromethorphan hydrobromide, guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58238-227-04 - Packager: Deliz Pharmaceutical Corp
- 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 November 2, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- TRISPEC DMX Cough Suppressant Expectorant Peach Flavor
- Active ingredients (in each 5 mL teaspoonful)
- Uses
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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. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- use only with enclosed measuring cup
- do not use enclosed measuring cup for any other drug product
Adults and children
12 years of age
and older:
2 teaspoonfuls (tsp) every 4 hours
not to exceed 8 teaspoonfuls in
24 hours, or as directed by a doctor.
Children 6 to under
12 years of age:
1 teaspoonful (tsp) every 4 hours
not to exceed 4 teaspoonfuls in
24 hours, or as directed by a doctor.
Children 2 to under
6 years of age:
½ teaspoonful (tsp) every 4 hours
not to exceed 2 teaspoonfuls in
24 hours, or as directed by a doctor.
- do not use enclosed measuring cup for any other drug product
- use only with enclosed measuring cup
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR 4 OZ/118 ML (58238-227-04)
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INGREDIENTS AND APPEARANCE
TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR
dextromethorphan hydrobromide, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58238-227 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 187 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) MALTITOL (UNII: D65DG142WK) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor PEACH Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58238-227-04 1 in 1 PACKAGE 11/18/2014 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 11/18/2014 Labeler - Deliz Pharmaceutical Corp (826391138) Establishment Name Address ID/FEI Business Operations Woodfield Pharmaceutical, LLC 079398730 manufacture(58238-227)
