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NDC 00067-8105-04 Triaminic 5; 2.5 mg/5mL; mg/5mL Details
Triaminic 5; 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 DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 00067-8105-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 00067-8105-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00067-8105 |
|---|---|
| Product ID | 0067-8105_a7817767-c6af-459c-b807-8a7aac951dea |
| Associated GPIs | 43995602151210 |
| GCN Sequence Number | 062332 |
| GCN Sequence Number Description | dextromethorphan/phenylephrine LIQUID 5-2.5 MG/5 ORAL |
| HIC3 | B4L |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT COMBINATIONS |
| GCN | 98110 |
| HICL Sequence Number | 000395 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Triaminic |
| Proprietary Name Suffix | Day Time Cold and Cough |
| Non-Proprietary Name | Dextromethorphan HBr, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 5; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 00067-8105-04 (00067810504)
| NDC Package Code | 0067-8105-04 |
|---|---|
| Billing NDC | 00067810504 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (0067-8105-04) / 118 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2012-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9437b637-fb70-41dd-8ead-d79698a61e22 Details
Uses
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 doctor before use if the 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
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 |
Inactive ingredients
Principal Display Panel
NDC 0067-8105-04
Children's
Triaminic®
Syrup
Day Time Cold & Cough
Ages 4 to 11 Years
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
*Stuffy Nose
*Cough
Cherry 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
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.
PARETNS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
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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INGREDIENTS AND APPEARANCE
| TRIAMINIC
DAY TIME COLD AND COUGH
dextromethorphan hbr, phenylephrine hcl syrup |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| L. Perrigo Company | 006013346 | MANUFACTURE(0067-8105) , PACK(0067-8105) , LABEL(0067-8105) | |