Label: CHILDREN ACETAMINOPHEN ORAL SOLUTION- acetaminophen liquid
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NDC Code(s):
17856-7014-1,
17856-7014-2,
17856-7014-3,
17856-7014-4, view more17856-7014-5, 17856-7014-6, 17856-7014-7, 17856-7014-8, 17856-7014-9
- Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 0904-7014
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 19, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- child takes more than 5 doses 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
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor before use if you have liver disease.
Ask a doctor before use if you are taking the blood thinning drug warfarin.
When using this product: Do not exceed recommended dose.
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present. These could be signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- do not take more than directed
- find dose in chart below
- if possible, use weight to dose, otherwise use age
- dosage may be repeasted 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 Teaspoonful (tsp) consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL) 4 tsp (20 mL) - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDREN ACETAMINOPHEN ORAL SOLUTION
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-7014(NDC:0904-7014) 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:17856-7014-1 72 in 1 BOX, UNIT-DOSE 04/19/2024 1 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:17856-7014-2 48 in 1 BOX, UNIT-DOSE 04/19/2024 2 5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:17856-7014-3 50 in 1 BOX, UNIT-DOSE 04/19/2024 3 15.6 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 4 NDC:17856-7014-4 120 in 1 BOX, UNIT-DOSE 04/19/2024 4 2.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 5 NDC:17856-7014-5 120 in 1 BOX, UNIT-DOSE 04/19/2024 5 1.25 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 6 NDC:17856-7014-6 120 in 1 BOX, UNIT-DOSE 04/19/2024 6 2.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 7 NDC:17856-7014-7 50 in 1 BOX, UNIT-DOSE 04/19/2024 7 20.31 mL in 1 CUP, UNIT-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 8 NDC:17856-7014-8 50 in 1 BOX, UNIT-DOSE 04/19/2024 8 31.2 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 9 NDC:17856-7014-9 72 in 1 BOX, UNIT-DOSE 04/19/2024 9 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M 10/01/2019 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations UNIT DOSE SOLUTIONS 360804194 repack(17856-7014)