Label: ACETAMINOPHEN elixir
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Contains inactivated NDC Code(s)
NDC Code(s): 71399-0161-4, 71399-0161-6, 71399-0161-8 - Packager: Akron Pharma Inc.
- 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.
Drug Label Information
Updated May 18, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL = 1 teaspoonful)
- Purpose
- Uses
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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.
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 non-prescription). 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 or pharmacist before use if your child is 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 5 days
- 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.
Keep out of 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 right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.
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Directions
- shake well before using
- find the right dose on chart below, if possible, use weight to dose; otherwise use age
- dosage may be repeated every 4 hours, or as directed by your doctor
- do not use more than 5 doses in 24 hours
- do not use more than 5 days unless directed by a doctor.
- find right dose on chart below, If possible, use weight to dose; otherwise, use age.
Weight (lbs.)
Age (years)
dosage-teaspoonful (tsp.)
under 24
under 2
consult Physician
24 to 35
2 to 3
1 tsp. (5 mL)
36 to 47
4 to 5
1 1/2 tsp. (7.5 mL)
48 to 59
6 to 8
2 tsp. (10 mL)
60 to 71
9 to 10
2 1/2 tsp. (12.5 mL)
72 to 95
11
3 tsp. (15 mL)
- Other information
- Inactive Ingredients:
- Questions or Comments?
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Principal Display Panel
• Compare To Active ingredient of Children's Tylenol Elixir
NDC 71399-0161-4
Children's
Pain Relief
Pain Reliever and
Fever ReducerAcetaminophen 160 mg per 5 ml Oral Elixir
• Alcohol Free
• Asprin Free
• For Ages 2 - 11 years
Grape Flavor
4 FL OZ (118 mL)
Akron Pharma
• Compare To Active ingredient of Children's Tylenol Elixir
NDC 71399-0161-8
Children's
Pain Relief
Pain Reliever and
Fever ReducerAcetaminophen 160 mg per 5 ml Oral Elixir
• Alcohol Free
• Asprin Free
• For Ages 2 - 11 years
Grape Flavor
8 FL OZ (236 mL)
Akron Pharma
• Compare To Active ingredient of Children's Tylenol Elixir
NDC 71399-0161-6
Children's
Pain Relief
Pain Reliever and
Fever ReducerAcetaminophen 160 mg per 5 ml Oral Elixir
• Alcohol Free
• Asprin Free
• For Ages 2 - 11 years
Grape Flavor
16 FL OZ (473 mL)
Akron Pharma
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen elixirProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-0161 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 GRAPE (UNII: 6X543N684K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71399-0161-4 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2021 2 NDC:71399-0161-8 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2021 3 NDC:71399-0161-6 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/18/2021 Labeler - Akron Pharma Inc. (067878881) Registrant - Akron Pharma Inc. (067878881) Establishment Name Address ID/FEI Business Operations SLV Pharmaceuticals LLC 081225162 manufacture(71399-0161)
