Label: ACETAMINOPHEN suspension
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NDC Code(s):
68094-231-01,
68094-231-58,
68094-231-59,
68094-231-61, view more68094-231-62
- Packager: Precision Dose, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0113-0212
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 11, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day 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.
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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child has ever had an allergic reaction to this product or any of its ingredients
When using this product do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
- 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.
- do not give this product to children for pain of arthritis unless directed by a doctor
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Directions
- Use as directed per healthcare professional.
- do not take more than directed (see overdose warning)
- shake well before using
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- do not take more than 5 times in 24 hours
- Other information
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Inactive ingredients
anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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How Supplied
NOC 68094-042-58
2.5 ml per unit dose ENFit syringe
Fifty (50) syringes per shipperNOC 68094-038-58
5 ml per unit dose ENFit syringe
Fifty (50) syringes per shipperNDC 68094-130-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipperNDC 68094-231-58
5 mL per unit dose syringe
Fifty (50) syringes per shipperNDC 68094-231-61
5 mL per unit dose cup
One hundred (100) cups per shipperNDC 68094-231-62
5 mL per unit dose cup
Thirty (30) cups per shipperNDC 68094-330-61
10.15 mL per unit dose cup
One hundred (100) cups per shipperNDC 68094-330-62
10.15 mL per unit dose cup
Thirty (30) cups per shipperNDC 68094-030-62
20.3 mL per unit dose cup
Thirty (30) cups per shipper - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
- PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-231(NDC:0113-0212) 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) calcium sulfate, unspecified form (UNII: WAT0DDB505) carrageenan (UNII: 5C69YCD2YJ) D&C red no. 33 (UNII: 9DBA0SBB0L) FD&C blue no. 1 (UNII: H3R47K3TBD) 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 (UNII: 506T60A25R) sodium phosphate, tribasic (UNII: A752Q30A6X) Product Characteristics Color PURPLE (viscous) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68094-231-62 3 in 1 CASE 04/01/2020 1 10 in 1 TRAY 1 NDC:68094-231-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:68094-231-61 10 in 1 CASE 04/01/2020 2 10 in 1 TRAY 2 NDC:68094-231-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 3 NDC:68094-231-58 5 in 1 CASE 07/31/2023 3 10 in 1 BAG 3 NDC:68094-231-01 5 mL in 1 SYRINGE, PLASTIC; 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 drug M013 04/01/2020 Labeler - Precision Dose, Inc. (035886746) Establishment Name Address ID/FEI Business Operations Precision Dose, Inc. 035886746 REPACK(68094-231)
