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

C:\Users\lucasry1\Desktop\Triaminic DT NT Combo Pack\2015-07-02_14-04-12.jpg
TRIAMINIC  DAY - NIGHT CLUB PACK
dextromethorphan, phenylephrine and diphenhydramine, phenylephrine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6417
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6417-121 in 1 BOX; Type 0: Not a Combination Product10/15/201205/29/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BOTTLE 1 mL
Part 20 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0043-6205-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/201105/29/2015
Part 2 of 2
TRIAMINIC  NIGHTTIME COLD AND COUGH
diphenhydramine, phenylephrine powder
Product Information
Item Code (Source)NDC:0043-6204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0043-6204-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/15/201205/29/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/15/201205/29/2015
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
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC