Label: CHILDRENS PAIN RELIEF COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
- 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.
Updated September 9, 2019
If you are a consumer or patient please visit this version.
- Active ingredients (in each 5 mL)
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
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
- 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.
- 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
under 4 years
do not use
4 to 5 years
do not use unless directed by a doctor
6 to 11 years
* 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
- Questions or comments?
Package/Label Principal Display Panel
Compare to the active ingredients of Children’s Tylenol® Cold + Flu Oral Suspension
FOR AGES 6-11 YEARS
CHILDREN’S PAIN RELIEF COLD & FLU
PAIN RELIEVER/FEVER REDUCER
relieves fever, sore throat, sneezing, runny nose, cough, and stuffy nose
alcohol free - aspirin free
ibuprofen free – gluten free
DOSAGE CUP INCLUDED
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF COLD AND FLU
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1023 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:11822-1023-1 1 in 1 CARTON 07/26/2019 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 07/26/2019 Labeler - Rite Aid Corporation (014578892)