| NDC | 0067-8105-04, 0067-8106-04, 0067-8112-08 |
| Set ID | 1f3a4082-78a3-468b-bd38-f2e64ac84f6b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Day Time Cold & Cough – Ages: 4 years & up
- 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 your 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
-
Directions
- •
- may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
- •
- use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.
Age
Dose
children under 4 years of age
do not use
children 4 to under 6 years of age
5 mL
children 6 to under 12 years of age
- 10 mL
- Other information
- Inactive ingredients
- Questions or comments?
- Night Time Cold & Cough – Ages: 6 years & up
- 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.
- •
- 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
- •
- 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
- •
- do not exceed recommended dosage
- •
- may cause marked drowsiness
- •
- sedatives and tranquilizers may increase drowsiness
- •
- excitability may occur, especially in children
-
Directions
- •
- may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
- •
- use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.
Age
Dose
children under 4 years of age
do not use
children 4 to under 6 years of age
do not use unless directed by a doctor
children 6 to under 12 years of age
10 mL
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Children’s Triaminic® Syrup
DAY/NIGHT VALUE PACK
Day Time Cold & Cough
Ages 4-11 Years
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
- •
- Stuffy Nose
- •
- Cough
Cherry Flavor
4 FL OZ (118 mL)
Night Time Cold & Cough
Ages 6 to 11 years
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal decongestant)
- •
- Cough Relief
- •
- Runny, Stuffy Nose
- •
- Itchy Throat
Grape Flavor
4 FL OZ (118 mL)
8 FL OZ (236 mL) TOTAL
Do not give both products at the same time or give more than 6 doses in total in any 24 hour period.
Child-Resistant Safety Cap.
Do not use if printed neckband is broken or missing.
What You Need to help Make Your Child Feel Better
PARENTS: Learn about teen medicine abuse
DO NOT GIVE THE FIRST DOSE OF NIGHT TIME COLD & COUGH SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAY TIME COLD & COUGH UNLESS DIRECTED BY A DOCTOR.
DO NOT GIVE BOTH PRODUCTS AT THE SAME TIME OR GIVE MORE THAN 6 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
Distributed by:
GSK Consumer Healthcare, Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies. ©2016 GSK group of companies or its licensor. All rights reserved.
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The Triaminic© brand provides a broad range of products, created with the needs of children in mind.
Trusted by Parents for over 50 years.
For more information plus helpful tips visit www.triaminic.com or call The Triaminic Clinic©, 1-800-KIDS-987
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INGREDIENTS AND APPEARANCE
TRIAMINIC DAY TIME COLD AND COUGH AND NIGHT TIME COLD AND COUGH
dextromethorphan hbr, phenylephrine hcl and diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8112 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8112-08 1 in 1 CARTON; Type 0: Not a Combination Product 01/01/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 118 mL Part 2 1 BOTTLE 118 mL Part 1 of 2 TRIAMINIC DAY TIME COLD AND COUGH
dextromethorphan hbr, phenylephrine hcl syrupProduct Information Item Code (Source) NDC:0067-8105 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) 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) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8105-04 118 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 10/15/2012 Part 2 of 2 TRIAMINIC NIGHT TIME COLD AND COUGH
diphenhydramine hcl, phenylephrine hcl syrupProduct Information Item Code (Source) NDC:0067-8106 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) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8106-04 118 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 10/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2016 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
