Acetaminophen
FDA Label NDC 71399-0161

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Acetaminophen (NDC 71399-0161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml = 1 teaspoonful), purpose, uses, warnings, do not use, ask a doctor before use if your child has, stop use and ask a doctor if:, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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.

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: 71399-0161-6SIZE 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 (Acetaminophen 118)

Acetaminophen 118 (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 (Acetaminophen 236)

Acetaminophen 236 (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 473)

Acetaminophen 473 (Acetaminophen 473)

* Please review the disclaimer below.