Label: DAYTIME NIGHTTIME COLD AND COUGH CHILDRENS- dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl kit
- NDC Code(s): 69842-422-08
- Packager: CVS Pharmacy
- 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 19, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients DayTime (in each 5 mL)
- Active ingredients for Nighttime (in each 5 mL)
- Purposes for Day Time
- Purpose for Night Time
-
Uses
DAYTIME
- temporarily relieves
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold
NIGHTTIME
-
temporarily relieves
- sneezing
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritations as may occur with a cold
- temporarily relieves
-
Warnings
Do not use
DAYTIME
- 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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
NIGHTTIME
- in a child under 4 years of age
- in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- with any other product containing diphenhydramine, even one used on skin
- for the purpose of making your child sleepy
Ask a doctor before use if the child has
DAYTIME
- 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
NIGHTTIME
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
- a breathing problem such as chronic bronchitis
When using this product
DAYTIME
do not exceed recommended dosage.
NIGHTTIME
- do not exceed recommended dosage
- marked drowsiness may occur
- excitability may occur, especially in children
- sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
DAYTIME
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
- cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.
These could be signs of a serious condition.
NIGHTTIME
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
- cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache.
These could be signs of a serious condition.
-
Directions
DAYTIME
- do not give 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 under 6 years of age 5 mL every 4 hours children under 4 years of age do not use
NIGHTTIME- Do not give more than 6 doses in 24 hours unless directed by a doctor
- 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 under 6 years of age do not use unless directed by a doctor children under 4 years of age do not use
- Other information
-
Inactive ingredients
Inactive ingredients for Day Time
acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium citrate
Inactive ingredients for Night Time
acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, Fd&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate
- Questions or comments?
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Principal Display Panel
Compare to the active ingredients in Children's Triaminic® Day Time Cold & Cough*
Daytime
Children's
Cold & Cough
DEXTROMETHORPHAN HBr Cough suppressant
PHENYLEPHRINE HCl Nasal decongestant
Relieves
- Cough
- Stuffy nose
Alcohol 0.14%
For Ages 4 to 11 Years
Cherry Flavor
Dosage cup included
FL OZ (mL)
Compare to the active ingredients in Children's Triaminic® Night Time Cold & Cough
Children's
Nighttime Cold & Cough
DIPHENHYDRAMINE HCI Antihistamine; Cough suppressant
PHENYLEPHRINE HCl Nasal decongestant
Relieves
- Cough
- Runny, stuffy nose
- itchy throat
Alcohol free
For Ages 6 to 11 Years
Grape Flavor
Dosage cup included
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Children's Triaminic® Day Time & Night Time Cold & Cough.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD AND COUGH CHILDRENS
dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-422 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-422-08 1 in 1 KIT; Type 0: Not a Combination Product 04/30/2018 04/30/2025 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 2 1 BOTTLE 118 mL Part 1 of 2 DAYTIME COLD COUGH CHILDRENS
dextromethorphan hbr, phenylephrine hcl liquidProduct Information 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 1 118 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 04/30/2018 Part 2 of 2 NIGHT TIME COLD AND COUGH CHILDREN
diphenhydramine hcl, phenylephrine hcl liquidProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 6.25 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) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 04/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/30/2018 04/30/2025 Labeler - CVS Pharmacy (062312574)
