ACETAMINOPHEN- acetaminophen elixir 
Akron Pharma Inc.

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.

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Acetaminophen Elixir

Grape Flavor

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:

Temporarily reduces fever.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

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

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

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: 71399-0161-6SIZE 473 ML
NDC: 71399-0161-8SIZE 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 - 07004

Manufactured 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 Reducer

Acetaminophen 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

acetaminophen 118

• Compare To Active ingredient of Children's Tylenol Elixir

NDC 71399-0161-8

Children's

Pain Relief

Pain Reliever and
Fever Reducer

Acetaminophen 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

acetaminophen 236

• Compare To Active ingredient of Children's Tylenol Elixir

NDC 71399-0161-6

Children's

Pain Relief

Pain Reliever and
Fever Reducer

Acetaminophen 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

acetaminophen 473

ACETAMINOPHEN 
acetaminophen elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-0161-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2021
2NDC:71399-0161-8236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2021
3NDC:71399-0161-6473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/18/2021
Labeler - Akron Pharma Inc. (067878881)
Registrant - Akron Pharma Inc. (067878881)
Establishment
NameAddressID/FEIBusiness Operations
SLV Pharmaceuticals LLC081225162manufacture(71399-0161)

Revised: 5/2021
Document Id: c29e2c3a-9ec6-0b62-e053-2a95a90ac69c
Set id: 66f4db9a-7bc3-4a9e-a696-a4be2f71e675
Version: 4
Effective Time: 20210518
 
Akron Pharma Inc.