Label: CHILDRENS PAIN AND FEVER DISSOLVE PACKS- acetaminophen powder
- NDC Code(s): 0363-5101-18
- Packager: WALGREENS CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each packet)
- Purpose
- 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.
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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- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
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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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- find right dose on chart. If possible, use weight to dose; otherwise, use age.
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- tear packet and pour powder on your child's tongue
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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 (yrs.) Dose (packets)** under 48
under 6 years
do not use
48-59
6-8 years
2 packets
60-71
9-10 years
2 packets
72-95
11 years
- 3
- packets
- Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL
NDC 0363-5101-18
Children's
Dye-Free
Pain & Fever Dissolve Packs
ACETAMINOPHEN 160 mg
PAIN RELIEVER/FEVER REDUCERDYE FREE, ASPIRIN FREE, IBUPROFEN FREE
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- No water needed
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- Dissolves in seconds
AGES 6-11 YEARS
18 PACKETS*
160 mg EACH PACKETWILD BERRY FLAVOR
NATURALLY AND ARTIFICIALLY FLAVORED
*PACKETS OF POWDER
Pour powder on your child’s tongue
IMPORTANT: Keep this carton for future reference on full labeling.
Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey
††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Children’s Tylenol® Dissolve Packs.
Distributed by:
WALGREEN CO.
200 WILMOT RD., CEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com © 2020 Walgreen Co.
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INGREDIENTS AND APPEARANCE
CHILDRENS PAIN AND FEVER DISSOLVE PACKS
acetaminophen powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg Inactive Ingredients Ingredient Name Strength citric acid monohydrate (UNII: 2968PHW8QP) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) ISOMALT (UNII: S870P55O2W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE (off white) Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-5101-18 18 in 1 CARTON 01/29/2020 1 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/29/2020 Labeler - WALGREENS CO. (008965063)