TRIAMINIC MULTI-SYMPTOM FEVER AND COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

Active ingredients (in each 5 mL)

Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg

Purposes

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Uses

temporarily relieves
o
minor aches and pains
o
headache
o
minor sore throat pain
o
runny nose
o
itchy nose or throat
o
sneezing
o
itchy, watery eyes due to hay fever
o
nasal and sinus congestion
o
cough due to minor throat and bronchial irritation as may occur with a cold
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

in a child under 4 years of age
if your child is allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
for the purpose of making your child sleepy

Ask a doctor before use if the child has

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a breathing problem such as chronic bronchitis
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, such as occurs with asthma

Ask a doctor or pharmacist before use if the child is

taking

sedatives or tranquilizers
the blood thinning drug warfarin

When using this product

do not exceed recommended dosage
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. 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. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

this product does not contain directions or complete warnings for adult use
do not give more than directed
shake well before use
may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
use enclosed dosing cup only. Keep for use with this product. 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
contains no aspirin
store at controlled room temperature 20-25°C (68-77°F). Protect from light.
close cap tightly

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum

Questions or comments?

call 1-800-452-0051

Principal Display Panel

NDC 0067-8116-04

Children’s

Triaminic®

Suspension

Multi-Symptom

Fever & Cold

Acetaminophen (Pain Reliever/Fever Reliever)

Chlorpheniramine maleate (Anithistamine)

Dextromethorphen HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Congestant)

Ages 6-11 Years

Cold & Flu Symptom Relief
Fever
Runny & Stuffy Nose
Aches & Pains
Sore Throat
Cough

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

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.

Distr. By: GSK Consumer Healthcare, Warren, NJ 07059

©2016 GSK or its licensor.

12680

Childrens Triaminic Suspension Multisymptom Fever Cold 4 fl oz (118 mL) carton
TRIAMINIC  MULTI-SYMPTOM FEVER AND COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8116
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8116-041 in 1 CARTON09/30/201308/31/2022
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/30/201308/31/2022
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2023
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC