Label: COLD AND COUGH DAY TIME CHILDRENS- dextromethorphan hbr, phenylephrine hcl liquid
- NDC Code(s): 55319-378-04
- Packager: Family Dollar (FAMILY WELLNESS)
- 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, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL)
- Purposes
- Uses
-
Warnings
Do not use
- in a child under 4 years of age
- in 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
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Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = milliliter
- shake well before using
age dose children 6 to under 12 years of age 10 mL every 4 hours children 4 to 5 years 5 mL every 4 hours children under 4 years do not use - Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S TRIAMINIC® DAYTIME COLD & COUGH*
FOR AGES 4 TO 11 YEARS
Children's
Cold & Cough Day Time
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
Alcohol 0.014%
Cherry Flavor
FL OZ (mL)
Dosage Cup Provided
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® DayTime Cold & Cough.
TAMPER EVIDENT:DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE RD MATTHEWS, NC 28105
- Package Label
-
INGREDIENTS AND APPEARANCE
COLD AND COUGH DAY TIME CHILDRENS
dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-378 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ALCOHOL (UNII: 3K9958V90M) BENZOIC ACID (UNII: 8SKN0B0MIM) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-378-04 1 in 1 BOX 08/31/2015 08/31/2025 1 118 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 08/31/2015 08/31/2025 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)