Label: CHILDRENS MULTI SYMPTOM FEVER AND COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
- NDC Code(s): 30142-023-26
- Packager: Kroger Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 15, 2020
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- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL)
- Purposes
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Uses
- •
- 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 has ever had an allergic reaction to this product or any of its ingredients
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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 giving this product.
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- to make a child sleepy
Ask a doctor before use if your 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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- persistent or chronic cough such as occurs with asthma
Ask a doctor or pharmacist before use your child is taking
- •
- sedatives or tranquilizers
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- the blood thinning drug warfarin
When using this product
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- 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 (see Overdose warning)
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- shake well before using
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- remove the child protective cap and squeeze your child’s dose into the dosing cup
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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.
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
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO the active ingredients of TRIAMINIC® MULTI-SYMPTOM FEVER & COLD
See side panel
OUR PHARMACIST RECOMMENDED
Ages 6 TO 11 Years
children’s Multi-Symptom Fever & Cold
Acetaminophen Pain Reliever/Fever Reducer
Chlorpheniramine Maleate Antihistamine
Dextromethorphan HBr Cough Suppressant
Phenylephrine HCl Nasal Decongestant
ORAL SUSPENSION
Cold & Flu Symptom Relief
Fever, Runny & Stuffy Nose, Aches & Pains, Sore Throat & Cough
Grape Flavor
4 FL OZ (118 mL)
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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:30142-023 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 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) XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505) SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X) Product Characteristics Color PURPLE (opaque) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-023-26 1 in 1 CARTON 06/23/2015 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 06/23/2015 Labeler - Kroger Company (006999528)
