Children’s Pain Relief

Children’s Pain Relief
SPL v1
SPL
SPL Set ID 0a9e0035-acd4-45ef-8ca5-3bbb66c7035f
Route
ORAL
Published
Effective Date 2020-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Grape Citric Acid Monohydrate Glycerin Polyethylene Glycol 400 Water Sodium Citrate, Unspecified Form Saccharin Sodium Sorbitol Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-28
Description

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

Acetaminophen 160 mg

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.

Section 50568-5

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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.

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)
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
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:

17856-5403-01 ACETAMINOPHEN - 2.5 ML SYRINGE 120 ct UD

17856-5403-02 ACETAMINOPHEN - 15.6 ML CUP 50 ct UD

17856-5403-03 ACETAMINOPHEN - 1.25 ML SYRINGE 120 ct UD

17856-5403-04 ACETAMINOPHEN - 3.75 ML CUP 72 ct UD

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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Principal Display Panel

• Compare To Active ingredient of Children's Tylenol Elixir

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

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.

Ask A Doctor Before Use If Your Child Has
  • •
    liver disease
  • •
    is on a sodium-restricted diet.
Active Ingredient (in Each 5 Ml = 1 Teaspoonful)

Acetaminophen 160 mg

Structured Label Content

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.

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain Reliever/Fever Reducer

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.

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)
Do Not Use (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
Other Information (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:

17856-5403-01 ACETAMINOPHEN - 2.5 ML SYRINGE 120 ct UD

17856-5403-02 ACETAMINOPHEN - 15.6 ML CUP 50 ct UD

17856-5403-03 ACETAMINOPHEN - 1.25 ML SYRINGE 120 ct UD

17856-5403-04 ACETAMINOPHEN - 3.75 ML CUP 72 ct UD

Questions Or Comments? (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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Principal Display Panel

• Compare To Active ingredient of Children's Tylenol Elixir

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

Stop Use and Ask A Doctor If: (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. (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.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)
  • •
    liver disease
  • •
    is on a sodium-restricted diet.
Active Ingredient (in Each 5 Ml = 1 Teaspoonful) (Active ingredient (in each 5 mL = 1 teaspoonful))

Acetaminophen 160 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:37.196102 · Updated: 2026-03-14T22:58:16.152732