Label: HEALTH MART CHILDRENS PAIN AND FEVER- acetaminophen suspension
- NDC Code(s): 62011-0183-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 28, 2020
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- Active ingredient (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
- 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.
- 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 2 years
ask a doctor
*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 Children’s Tylenol® Oral Suspension active ingredient
Children’s Pain & Fever
Acetaminophen 160 mg per 5 mL
Pain Reliever/Fever Reducer
For ages 2 to 11 years
No high fructose corn syrup
4 Fl oz (118 mL)
INGREDIENTS AND APPEARANCE
HEALTH MART CHILDRENS PAIN AND FEVER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0183 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) CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505) CARRAGEENAN (UNII: 5C69YCD2YJ) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X) Product Characteristics Color WHITE (viscous) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0183-1 1 in 1 CARTON 01/17/2013 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 not final part343 01/17/2013 Labeler - Strategic Sourcing Services LLC (116956644)