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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
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- Active ingredient (in each 5 mL = 1 teaspoonful)
Acetaminophen 160 mg
- Purpose
Pain Reliever/Fever Reducer
- Uses
To reduce fever and for the temporary relief of minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps.
Temporarily reduces fever.
- 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 before use if your child has
- liver disease
- is on a sodium-restricted diet.
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.
If pregnant or breast-feeding, ask a health professional before use.
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.
- 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
- Store at room temperature 15°-30° C (59°-86°F)
- Protect from Freezing.
- Protect from Light.
TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
- Inactive Ingredients:
Grape Flavor, Citric Acid, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.
How Supplied
NDC: 71399-0161-6 SIZE 473 ML NDC: 71399-0161-8 SIZE 236 ML NDC: 71399-0161- 4 SIZE 118 ML - Questions or Comments?
Call (877) 225-6999 Monday - Friday 9AM-5PM EST
Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004Manufactured In USA
* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir
- 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
See AlsoParacetamol 120mg/5ml Oral Suspension (04917/0028) - Summary of Product Characteristics (SmPC)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
- 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 160mg in5mL 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)
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Safety
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Related Resources
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More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
ACETAMINOPHEN elixir
Number of versions: 3
| Published Date (What is this?) | Version | Files |
|---|---|---|
| May 19, 2021 | 4 (current) | download |
| May 5, 2021 | 2 | download |
| Jul 30, 2020 | 1 | download |
RxNorm
ACETAMINOPHEN elixir
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN |
| 2 | 307675 | acetaminophen 32 MG/ML Oral Solution | SCD |
| 3 | 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY |
| 4 | 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY |
| 5 | 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY |
| 6 | 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY |
| 7 | 307675 | APAP 32 MG/ML Oral Solution | SY |
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NDC Codes
ACETAMINOPHEN elixir
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 71399-0161-4 (inactivated) |
| 2 | 71399-0161-6 (inactivated) |
| 3 | 71399-0161-8 (inactivated) |
