Label: ACETAMINOPHEN liquid
- 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 September 24, 2018
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredient (in each 5mL)
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 fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use • with any other product 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 of the inactive ingredients in this product
Ask a doctor before use if your child has liver disease
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
When using this product, do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
• pain gets worse or last for more than 5 days
• fever gets worse or last for more than 3 days
• new symptoms occur • redness or swelling is present
These could be signs of a serious condition.
KEEP OUT OF REACH OF CHILDREN
Keep out of the 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 children even if you do not notice any signs or symptoms.
• this product does not contain directions or complete warnings for adult use
• find right dose on chart. If possible, use weight to dose; otherwise, use age
• mL = milliliter
• if needed, repeat dose every 4 hours
• do not use more than 5 doses in 24 hours
• use enclosed dosing cup only. Do not use any other device
Weight Age Dose under 24 lbs Under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 5mL 36 to 47 lbs 4 to 5 years 7.5mL 48 to 59 lbs 6 to 8 years 10mL 60 to 71 lbs 9 to 10 years 12.5mL 72 to 95 lbs 11 years 15mL
- Inactive ingredients
- Other information
- Questions or Comments?
SPL UNCLASSIFIED SECTION
Fast, Effective Relief of Children's Fever and Pain
- Alcohol Free
- Aspirin Free
- Cherry Flavor
DOSAGE CUP ENCLOSED
COMPARE TO the active ingredient of TYLENOL®*LIQUID
Child-Resistant Safety Cap Unbreakable Bottle
* Delsam Pharma Llc is not affiliated with the owner of the registered trademark Tylenol®
Delsam Pharma Llc
Bronx, Newyork 10467
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72570-100 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 METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) POVIDONE K30 (UNII: U725QWY32X) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 33 (UNII: 9DBA0SBB0L) WATER (UNII: 059QF0KO0R) Product Characteristics Color red (pinkish red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72570-100-04 1 in 1 CARTON 09/25/2018 1 118 mL in 1 BOTTLE, PLASTIC; 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 09/25/2018 Labeler - Delsam Pharma Llc (081369679)