FDA Label for Triaminic Day Time Cold And Cough And Night Time Cold And Cough
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 5 ML)
- PURPOSES
- USES
- 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?
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- PRINCIPAL DISPLAY PANEL
Triaminic Day Time Cold And Cough And Night Time Cold And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
Purposes
Cough suppressant
Nasal decongestant
Antihistamine/cough suppressant
Nasal decongestant
Uses
• temporarily relieveso nasal and sinus congestiono cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily relieveso sneezingo itchy nose or throato runny noseo itchy, watery eyes due to hay fevero nasal and sinus congestiono cough due to minor throat and bronchial irritation as may occur with a cold
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.• 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 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• 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.• 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.
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.• 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 |
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
• store at 20°-25°C (68°-77°F)• 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 red no. 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
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
call 1-800-452-0051
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
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• Cough Relief• Runny, Stuffy Nose• Itchy Throat
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)
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.
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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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For more information plus helpful tips visit www.triaminic.com or call The Triaminic Clinic©, 1-800-KIDS-987
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