CHILDRENS MULTI SYMPTOM FEVER AND COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

childrens Multi Symptom Fever and Cold by

Drug Labeling and Warnings

childrens Multi Symptom Fever and Cold by is a Otc medication manufactured, distributed, or labeled by WALGREEN CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.
• 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
• Tamper–evident: 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

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

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walgreens.com ©2017 Walgreen Co.

INGREDIENTS AND APPEARANCE

CHILDRENS MULTI SYMPTOM FEVER AND COLD 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

Product 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)