Label: ACETAMINOPHEN liquid
- NDC Code(s): 48433-401-05, 48433-401-25
- Packager: Safecor Health, LLC
- This is a repackaged label.
- Source NDC Code(s): 54859-809
- 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 December 28, 2022
If you are a consumer or patient please visit this version.
- Active Ingredient (per 5 mL = 1 teaspoonful)
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:
- more than 5 doses is taken in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday while using this product
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.
- Do not use
- Ask a doctor before use if you have
- Ask a doctor before use if you are
- When using this product: Do not exceed recommended dose.
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Do not take more than directed
- Find dose in chart below
- If possible, use weight to dose, otherwise use age
- Dosage may be repeated every 4 hours, or as directed by a doctor
- Do not give more than 5 doses in 24 hours
Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95 over 95 Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult Dosage mL (tsp) Consult Physician 5 mL (1 tsp ) 7.5 mL (1 1/2 tsp) 10 mL (2 tsp) 12.5 mL (2 1/2 tsp) 15 mL (3 tsp) 20 mL (4 tsp)
- Other Information:
- Inactive Ingredients:
SPL UNCLASSIFIED SECTION
NDC: 48433-401-05 Acetaminophen Oral Liquid Unit Dose Oral ENFit® Syringe (160 mg / 5 mL)
NDC: 48433-401-25 Box of 25 Unit-Dose Oral ENFit® Syringes, each unit-dose syringe delivers 5 mL
For Oral Use Only.
For Institutional Use Only.
This Package Is Not Child Resistant.
Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204 Rev: 07/2022 PN5727
- Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48433-401(NDC:54859-809) 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) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48433-401-25 25 in 1 BOX 11/01/2022 1 NDC:48433-401-05 5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/01/2022 Labeler - Safecor Health, LLC (828269675) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 078805287 repack(48433-401) , relabel(48433-401)