TRIAMINIC DAY TIME COLD AND COUGH AND NIGHT TIME COLD AND COUGH- dextromethorphan hbr, phenylephrine hcl and diphenhydramine hcl, phenylephrine hcl kit

Triaminic by

Drug Labeling and Warnings

Triaminic by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Day Time Cold & Cough – Ages: 4 years & up

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves
  • o nasal and sinus congestion
  • o cough due to minor throat and bronchial irritation as may occur with a cold

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

When using this product

• do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs
• 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

• store at 20°-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

call 1-800-452-0051

Night Time Cold & Cough – Ages: 6 years & up

Active ingredients (in each 5 mL)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine/cough suppressant

Nasal decongestant

Uses

• temporarily relieves
  • o sneezing
  • o itchy nose or throat
  • o runny nose
  • o itchy, watery eyes due to hay fever
  • o nasal and sinus congestion
  • o cough due to minor throat and bronchial irritation as may occur with a cold

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

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

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

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs
• 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

• each 5 mL contains: sodium 3 mg
• store at 20°-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

call 1-800-452-0051

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

www.StopMedicineAbuse.org

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

INGREDIENTS AND APPEARANCE

TRIAMINIC  DAY TIME COLD AND COUGH AND NIGHT TIME COLD AND COUGH
dextromethorphan hbr, phenylephrine hcl and diphenhydramine hcl, phenylephrine hcl kit

Product 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 syrup

Product 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 syrup

Product 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)