Drug Facts

Drug Details [pdf]

TRIAMINIC DAY - NIGHT CLUB PACK- dextromethorphan, phenylephrine and diphenhydramine, phenylephrine
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

Daytime Cold & Cough – Ages: 4 years & up

Active ingredients (in each 5 mL, 1 teaspoonful)

Dextromethorphan hydrobromide, 12.5 mg

Phenylephrine hydrochloride, 5 mg

Purpose

Cough suppressant

Nasal decongestant

Uses

temporarily relieves
nasal and sinus congestion
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

Age	Dose
children under 4 years of age	do not use
children 4 to under 6 years of age	1 teaspoonful (5 mL)
children 6 to under 12 years of age	2 teaspoonfuls (10 mL)

Other information

each teaspoonful contains: sodium 2 mg
store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

acesulfame K, benzoic acid, citric acid, edetate disodium, FD&C red #40, flavors, maltitol solution, propylene glycol, purified water, sodium citrate

Questions or Comments?

call 1-800-452-0051 24 hours a day, 7 days a week

Nighttime Cold & Cough – Ages: 6 years & up

Active ingredients (in each 5 mL, 1 teaspoonful)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purpose

Antihistamine/cough suppressant

Nasal decongestant

Uses

temporarily relieves
Sneezing
itchy nose or throat
runny nose
itchy, watery eyes due to hay fever
nasal and sinus congestion
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	teaspoonfuls (10 mL)

Other information

each teaspoonful 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

call 1-800-452-0051 24 hours a day, 7 days a week

Principal Display Panel

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TRIAMINIC DAY - NIGHT CLUB PACK
dextromethorphan, phenylephrine and diphenhydramine, phenylephrine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-6417

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0067-6417-12	1 in 1 BOX; Type 0: Not a Combination Product	10/15/2012	05/29/2015

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	0 BOTTLE	1 mL
Part 2	0 BOTTLE	2 mL

Part 1 of 2

TRIAMINIC DAYTIME COLD AND COUGH
dextromethorphan, phenylephrine syrup

Product Information
Item Code (Source)	NDC: 0043-6205
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0043-6205-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/01/2011	05/29/2015

Part 2 of 2

TRIAMINIC NIGHTTIME COLD AND COUGH
diphenhydramine, phenylephrine powder

Product Information
Item Code (Source)	NDC: 0043-6204
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0043-6204-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/15/2012	05/29/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/15/2012	05/29/2015

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 8/2019

Document Id: ce900b7b-d80e-4b42-86ba-2df46ee801b6

Set id: 3b234645-70a7-4a30-8754-1c51c5f48052

Version: 2

Effective Time: 20190830

GlaxoSmithKli

Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Daytime Cold & Cough – Ages: 4 years & up

Active ingredients (in each 5 mL, 1 teaspoonful)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if your child has

When using this product

Stop use and ask a doctor if

Keep Out of Reach of Children

Directions

Other information

Inactive ingredients

Questions or Comments?

Nighttime Cold & Cough – Ages: 6 years & up

Active ingredients (in each 5 mL, 1 teaspoonful)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if the child has

Ask a doctor or pharmacist before use if the child is

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions

Principal Display Panel