Label: CHILDRENS PAIN RELIEF liquid
- NDC Code(s): 69168-455-53
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 11, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
-
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 ever, 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.
■ If your child is allergic to acetaminophen or any other of the inactive ingredients in this product.
Stop use and ask a doctor if
■ pain gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 days ■ new symptoms ■ redness or swelling is present. These could be signs of a serious condition.
Keep out of reach of children
Overdose warning: Taking more than the recommended dose (overdose) may
cause liver damage. In case of overdose, get medical help or contact a Poison
Control Center (1-800-222-1222) right away. Quick medical attention is critical
for adults as well as for children even if you do not notice any signs or
symptoms. -
Directions
■ this product does not contain directions or complete warnings for adult use.■ shake well before using
■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours
■ do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Dose (mL)* under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL(1 tsp)
36-47
4-5 years
7.5 mL(1 1/2 tsp)
48-59
6-8 years
10 mL(2 tsp)
60-71
9-10 years
12.5 mL(2 1/2 tsp)
72-95
11 years
15 mL(3 tsp)
*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/Comments
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF
childrens pain relief liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-455 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 Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLPARABEN (UNII: 3QPI1U3FV8) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-455-53 1 in 1 CARTON 04/11/2024 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 Drug M013 04/11/2024 Labeler - Allegiant Health (079501930)