![CHILDRENS MULTI SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [WALGREEN CO.]](https://medic.hrt.org//dailymed/images/cea507f3-86d6-4a68-9635-c4e4ca0f8fda/12680 Childrens Triaminic Suspension Multisymptom Fever Cold 4 fl oz (118 mL) carton.jpg)
| NDC | 0363-0789-04 |
| Set ID | cea507f3-86d6-4a68-9635-c4e4ca0f8fda |
| Category | HUMAN OTC DRUG LABEL |
| Packager | WALGREEN CO. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 5 mL)
- Purposes
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Uses
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- temporarily relieves
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- minor aches and pains
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- headache
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- minor sore throat pain
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- runny nose
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- itchy nose or throat
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- sneezing
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- itchy, watery eyes due to hay fever
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- nasal and sinus congestion
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- cough due to minor throat and bronchial irritation as may occur with a cold
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- temporarily reduces fever
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
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- more than 5 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- in a child under 4 years of age
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- if your child is allergic to acetaminophen
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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 taking this product.
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- for the purpose of making your child sleepy
Ask a doctor before use if the child has
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- glaucoma
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- a breathing problem such as chronic bronchitis
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- cough that occurs with too much phlegm (mucus)
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- chronic cough that lasts, such as occurs with asthma
Ask a doctor or pharmacist before use if the child is
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
- •
- do not exceed recommended dosage
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- marked drowsiness may occur
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- sedatives and tranquilizers may increase drowsiness
- •
- excitability may occur, especially in children
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occur
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- pain, nasal congestion or cough gets worse or lasts more than 5 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed
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- shake well before use
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- 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.
- •
- mL = milliliter
Age
Dose
children under 4 years
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
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
NDC 0363-0789-04
Walgreens
Compare to Children’s Triaminic® Suspension
Multi-Symptom Fever & Cold active ingredients††
NEW
children’s Multi-Symptom Fever & Cold
ACETAMINOPHEN /
PAIN RELIEVER/FEVER RELIEVER
CHLORPHENIRAMINE MALEATE /
ANITHISTAMINE
DEXTROMETHORPHAN HBR /
COUGH SUPPRESSANT
PHENYLEPHRINE HCL /NASAL CONGESTANT
- •
- Relief of cold & flu symptoms; fever; runny & stuffy nose; aches & pains; sore throat; Cough
AGES 6-11 YEARS
GRAPE FLAVOR
Naturally and Artificially flavored
4 FL OZ (118 mL)
PHARMACIST RECOMMENDED
WALGREENS
†Walgreens Pharmacist Survey
IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING
††This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Children’s Triaminic Suspension Multi-Symptom Fever and Cold
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens 100% SATISFACTION GUARANTEED
walgreens.com ©2017 Walgreen Co.
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INGREDIENTS AND APPEARANCE
CHILDRENS MULTI SYMPTOM FEVER AND COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0789 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0789-04 1 in 1 CARTON 09/01/2017 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/01/2017 Labeler - WALGREEN CO. (008965063)
