Label: CHILDRENS PAIN RELIEF COLD AND COUGH AND SORE THROAT- acetaminophen, dextromethorphan hydrobromide suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-2023-1 - Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
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 August 5, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL)
- Purposes
- Uses
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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.
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Do not use
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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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- 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
- Ask a doctor or pharmacist before use if your child is
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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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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- mL = milliliter
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- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
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- remove the child protective cap and squeeze your child’s dose into the dosing cup
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- repeat dose every 4 hours, while symptoms last
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- 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
5 mL
48-95
6 to 11 years
10 mL
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?
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Package/Label Principal Display Panel
Compare to the active ingredients of Children’s Tylenol® Cold + Cough + Sore Throat Oral Suspension
children’s pain relief cold & cough & sore throat
fever & sore throat (acetaminophen)
cough (dextromethorphan HBr)
pain reliever/fever reducer
cough suppressant
oral suspension
alcohol free
aspirin free
bubble gum flavor
ibuprofen free
gluten-free
for ages 4-11 years
dosage cup included
4 FL OZ (118 mL)
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INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF COLD AND COUGH AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-2023 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 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 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 PINK Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-2023-1 1 in 1 CARTON 07/29/2019 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 07/29/2019 Labeler - Rite Aid Corporation (014578892)