Indications and uses
• temporarily relieves o nasal and sinus congestion o cough due to minor throat and bronchial irritation as may occur with a cold
Triaminic
- Manufacturer
- GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Effective date
- 2016-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:00:14
Label at a glance#
ProductTriaminic Day Time Cold and Cough and Night Time Cold and Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections
Dosage and administration
• 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
Storage and handling
• store at 20°-25°C (68°-77°F)
Contacts and useful links#
Websitewww.stopmedicineabuse.org
www.StopMedicineAbuse.org
www.StopMedicineAbuse.orgWebsitewww.triaminic.com
www.triaminic.com
www.triaminic.comLabel contents#
Full prescribing information#
Active ingredients (in each 5 mL)
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Purposes
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.
- 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 |
|
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
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
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0067-8112-08 | 2024-08-15 | C162847 | 48780-1 | ba0f9c33-2d1e-a910-e053-dadaa90a0b85 | Drug Facts |
| 0067-8112-08 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2d1e-a910-e053-dadaa90a0b85 | Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-8105-04 | ML - Milliliter | 0067-8105 | 3f888eda-9a80-4fed-a94f-c8c085c844e9 | 1 | 2013-02-13 |
| 0067-8106-04 | ML - Milliliter | 0067-8106 | 7077040a-9f63-420a-8014-0986e254c269 | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- Triaminic Day Time Cold and Cough and Night Time Cold and Cough
- Dextromethorphan HBr, Phenylephrine HCl and Diphenhydramine HCl, Phenylephrine HCl
- Triaminic Day Time Cold and Cough
- Dextromethorphan HBr, Phenylephrine HCl
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C RED NO. 40
- MALTITOL
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE, UNSPECIFIED FORM
- Triaminic Night Time Cold and Cough
- Diphenhydramine HCl, Phenylephrine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0067-8112 | 0067-8112-08 |
| 0067-8105 | 0067-8105-04 |
| 0067-8106 | 0067-8106-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1fb926a4-0f35-49b6-e063-6294a90a3a88 | 1f3a4082-78a3-468b-bd38-f2e64ac84f6b | 2024-08-15 | Warnings | 1f3a4082-78a3-468b-bd38-f2e64ac84f6b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.