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NDC 00067-8106-04 TRIAMINIC 6.25; 2.5 mg/5mL; mg/5mL Details

TRIAMINIC 6.25; 2.5 mg/5mL; mg/5mL

TRIAMINIC is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00067-8106-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 00067-8106-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	00067-8106
Product ID	0067-8106_893f86bf-9058-4b2f-a703-e25174cda029
Associated GPIs	43993002951220
GCN Sequence Number	062346
GCN Sequence Number Description	phenylephrine/diphenhydramine LIQUID 2.5-6.25/5 ORAL
HIC3	Z2N
HIC3 Description	1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	98124
HICL Sequence Number	019892
HICL Sequence Number Description	PHENYLEPHRINE HCL/DIPHENHYDRAMINE HCL
Brand/Generic	Brand
Proprietary Name	TRIAMINIC
Proprietary Name Suffix	Night Time Cold and Cough
Non-Proprietary Name	Diphenhydramine HCl, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	SYRUP
Route	ORAL
Active Ingredient Strength	6.25; 2.5
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2022-12-31

Package

Package Images

NDC 00067-8106-04 (00067810604)

Pricing Information	N/A
NDC Package Code	0067-8106-04
Billing NDC	00067810604
Package	118 mL in 1 BOTTLE (0067-8106-04)
Marketing Start Date	2012-10-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 40ae8bfc-4007-4483-bb08-cf32f2e802c6 Details

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

•: 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	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

Distributed by:

GSK Consumer Healthcare, Warren, NJ 07059

Principal Display Panel

NDC 0067-8106-04

Ages 6 to 11 years

Children’s Triaminic® Syrup

Night Time Cold & Cough

Diphenhydramine HCl (Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

•: Cough Relief
•: Runny, Stuffy Nose
•: Itchy Throat

Grape Flavor

4 Fl OZ (118 mL)

Child-Resistant Safety Cap.

Do not use if printed neckband is broken or missing.

What You Need to Help Make Your Child Feel Better

Night Time Cold & Cough

•: Cough Relief
•: Runny, Stuffy Nose
•: Itchy Throat

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

12682

INGREDIENTS AND APPEARANCE

TRIAMINIC NIGHT TIME COLD AND COUGH

diphenhydramine hcl, phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-8106
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)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-8106-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2012

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

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

Revised: 12/2020

Document Id: 893f86bf-9058-4b2f-a703-e25174cda029

Set id: 40ae8bfc-4007-4483-bb08-cf32f2e802c6

Version: 3

Effective Time: 20201211