![COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]](https://medic.hrt.org//dailymed/images/baf09ef5-9933-43fa-8f14-6a0f9de9bf62/cvs-44-040-discontinued-1.jpg)
| NDC | 69842-940-19 |
| Set ID | baf09ef5-9933-43fa-8f14-6a0f9de9bf62 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CVS Pharmacy |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 10 mL)
- Purpose
-
Uses
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- itchy, watery eyes
- runny nose
- sneezing
- itching of the nose or throat
- temporarily restores freer breathing through the nose
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold
-
Warnings
Do not use
- to make a child sleepy
- 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.
Ask a doctor before use if you have
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- glaucoma
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
When using this product
-
do not exceed recommended dosage
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- to make a child sleepy
-
Directions
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- do not take more than 6 doses in any 24-hour period
Age Dose adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use - mL = milliliter; FL OZ = fluid ounce
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
VALUE SIZE
CVS
Health™Compare to the active
ingredients in Children's
Dimetapp® Cold & Cough*Grape Flavor
Children's
Cold &
CoughBROMPHENIRAMINE
MALEATE
Antihistamine
DEXTROMETHORPHAN HBr
Cough Suppressant
PHENYLEPHRINE HCl
Nasal DecongestantLiquid
Relieves:
Nasal congestion, Stuffy nose,
Runny nose, Sneezing
Soothes coughAlcohol free
Grape Flavor
For Ages 6 Years & OverActual Bottle Size
on Side Panel8 FL OZ (237 mL)
Package Contains One Bottle
Actual SizeCVS Health™ Children’s Cold & Cough
offers grape-favored relief from nasal
congestion, runny nose, coughing and
sneezing to get through the day.*This product is not manufactured or distributed
by Wyeth LLC, owner of the registered trademark
Children’s Dimetapp® Cold & Cough.Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-19849CVS®Quality
Money Back GuaranteeTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGPARENTS:
Learn about teen drug abuse
www.StopMedicineAbuse.org
CVS Health 44-040
-
INGREDIENTS AND APPEARANCE
COLD AND COUGH CHILDRENS
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-940 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 2 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength 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) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-940-19 1 in 1 CARTON 07/02/2018 04/15/2022 1 237 mL in 1 BOTTLE, PLASTIC; 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 07/02/2018 04/15/2022 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 MANUFACTURE(69842-940) , PACK(69842-940)