CHILDRENS COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspension
childrens cold and flu by
Drug Labeling and Warnings
childrens cold and flu by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each 5 mL)
- Purpose
- Uses
-
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- to make a child sleepy
- 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.
- if your child has ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if your child has
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as chronic bronchitis
Ask a doctor or pharmacist before use if your child is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage (see overdose warning)
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
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.
-
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see overdose warning)
- shake well before using
- mL = milliliter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- remove the child protective cap and squeeze your child’s dose into the dosing cup
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Weight (lb)
Age (yr)
Dose (mL)*
under 36
under 4 years
do not use
36-47
4 to 5 years
do not use unless directed by a doctor
48-95
6 to 11 years
10 mL
* or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- Other information
- Inactive ingredients
-
Package/Label Principal Display Panel
FOR AGES 6 to 11 YEARS
CHILDREN’S cold & flu
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCER
CHLORPHENIRAMINE MALEATE, ANTIHISTAMINE, DEXTROMETHORPHAN HBr, COUGH SUPPRESSANT, PHENYLEPHRINE HCl, NASAL DECONGESTANT
ORAL SUSPENSION
FAST, EFFECTIVE RELIEF OF CHILDREN’S PAIN & FEVER
Relief of:
Fever
Sore throat
Sneezing
Runny nose
Cough
Stuffy nose
GRAPE FLAVOR
Compare to the active ingredients in Children’s Tylenol® Cold + Flu
4 FL OZ (120 mL)
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INGREDIENTS AND APPEARANCE
CHILDRENS COLD AND FLU
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 56062-239 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) CALCIUM SULFATE (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 Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 56062-239-26 1 in 1 CARTON 09/21/2019 1 120 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 09/21/2019 Labeler - Publix Super Markets Inc (006922009)
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