Childrens multi symptom fever and cold suspension

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
    • minor aches and pains
    • headache
    • minor sore throat pain
    • runny nose
    • itchy nose or throat
    • sneezing
    • 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
  • 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 Parkinsons disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your childs prescription drug contains an MAOI, ask a doctor or pharmacist before taking 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
  • taking 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 at 1-800-222-1222. 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.
  • 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

  • each 5 mL contains: sodium 5 mg
  • Tamperevident: do not use if printed inner seal under cap is torn or missing
  • store at room temperature. Protect from light.
  • contains no aspirin
  • close cap tightly

Inactive ingredients

citric acid, D&C Red #33, edetate disodium, FD&C Blue #1, FD&C Red #40, flavor, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucrose, xanthan gum

Questions or comments?

1-866-467-2748

Ingredients and appearance - Product information

Childrens multi symptom fever and cold suspension- Acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0363-0789
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 160 mgin 5 mL
Chlorpheniramine maleate ( UNII: V1Q0O9OJ9Z)( Chlorpheniramine - UNII: 3U6IO1965U ) 1 mgin 5 mL
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 5 mgin 5 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 2.5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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 Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - WALGREEN CO.( 008965063)

Principal display panel

NDC 0363-0789-04

Walgreens

Compare to Childrens Triaminic ®Suspension

Multi-Symptom Fever & Cold active ingredients

NEW

childrens 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 Childrens Triaminic Suspension Multi-Symptom Fever and Cold

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

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