Premier Value Junior Strength Pain Reliever

Premier Value Junior Strength Pain Reliever
SPL v7
SPL
SPL Set ID d356bc9c-66f1-45c3-a455-98c0b8890f78
Route
ORAL
Published
Effective Date 2024-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Crospovidone (120 .mu.m) D&c Red No. 30 Dextrose, Unspecified Form Fd&c Blue No. 1 Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Maltodextrin Silicon Dioxide Carboxymethylcellulose Sodium, Unspecified Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP160 Shape: round Color: purple Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-07
Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses
  • ▪
    temporarily relieves minor aches and pains due to:
    • ▪
      the common cold
    • ▪
      flu
    • ▪
      headache
  • ▪
    temporarily reduces fever
Warnings

Liver warning:  This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • ▪
    more than 5 doses in 24 hours, which is the maximum daily amount
  • ▪
    with other drugs containing acetaminophen

Allergy Alert: Acetaminophen may cause severe skin reaction. Symptoms may include:

  • ▪
    Skin reddening
  • ▪
    Blister
  • ▪
    Rash If a skin reaction occurs, stop use and seek medical help right away

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
  • ▪
    this product does not contain directions or complete warnings for adult use
  • ▪
    do not give more than directed (see overdose warning)
  • ▪
    find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • ▪
    chew completely do not swallow whole
  • ▪
    repeat dose every 4 hours while symptoms last
  • ▪
    do not give more than 5 times in 24 hours

 Weight (lbs)

 Age (yr)

 Tablets

 under 24

 under 2 years

 Ask a doctor

 24-35

 2-3 years

 1 tablets

 36-47

 4-5 years

 1½ tablets

 48-59

60-71

72-95

6-8 years

9-10 years

11 years

 2 tablets

2½ tablets

3 tablets

*or as directed by a doctor

Do Not Use
  • ▪
    with any other drug containing acetaminophen (prescription or nonprescription). 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. Avoid high humidity. Protect from light
  • ▪
    see end flap for expiration date and lot number
Inactive Ingredients

citric acid, crospovidone, D&C Red no. 30 lake, dextrose, FD&C Blue no. 1 lake, flavors, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethyl cellulose, starch sucralose

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN CHILDREN’S TYLENOL® CHEWABLES*

Premier Value®

Children’s Pain Reliever Chewables



ACETAMINOPHEN

Pain Reliever/Fever Reducer

Aspirin-Free

Ibuprofen-Free

Grape Flavor

Naturally and Artificially Flavored



24 CHEWABLES TABLETS - 160 mg each

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue, Wayne, PA

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol® Chewables.

When Using This Product

Do not exceed recommended dosage (see overdose warning).

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: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet)

Acetaminophen 160 mg

Ask A Doctor Before Use If Your Child Has

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

Structured Label Content

Uses
  • ▪
    temporarily relieves minor aches and pains due to:
    • ▪
      the common cold
    • ▪
      flu
    • ▪
      headache
  • ▪
    temporarily reduces fever
Purpose

Pain reliever/fever reducer

Warnings

Liver warning:  This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • ▪
    more than 5 doses in 24 hours, which is the maximum daily amount
  • ▪
    with other drugs containing acetaminophen

Allergy Alert: Acetaminophen may cause severe skin reaction. Symptoms may include:

  • ▪
    Skin reddening
  • ▪
    Blister
  • ▪
    Rash If a skin reaction occurs, stop use and seek medical help right away

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
  • ▪
    this product does not contain directions or complete warnings for adult use
  • ▪
    do not give more than directed (see overdose warning)
  • ▪
    find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • ▪
    chew completely do not swallow whole
  • ▪
    repeat dose every 4 hours while symptoms last
  • ▪
    do not give more than 5 times in 24 hours

 Weight (lbs)

 Age (yr)

 Tablets

 under 24

 under 2 years

 Ask a doctor

 24-35

 2-3 years

 1 tablets

 36-47

 4-5 years

 1½ tablets

 48-59

60-71

72-95

6-8 years

9-10 years

11 years

 2 tablets

2½ tablets

3 tablets

*or as directed by a doctor

Do Not Use (Do not use)
  • ▪
    with any other drug containing acetaminophen (prescription or nonprescription). 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. Avoid high humidity. Protect from light
  • ▪
    see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

citric acid, crospovidone, D&C Red no. 30 lake, dextrose, FD&C Blue no. 1 lake, flavors, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethyl cellulose, starch sucralose

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN CHILDREN’S TYLENOL® CHEWABLES*

Premier Value®

Children’s Pain Reliever Chewables



ACETAMINOPHEN

Pain Reliever/Fever Reducer

Aspirin-Free

Ibuprofen-Free

Grape Flavor

Naturally and Artificially Flavored



24 CHEWABLES TABLETS - 160 mg each

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue, Wayne, PA

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol® Chewables.

When Using This Product (When using this product)

Do not exceed recommended dosage (see overdose warning).

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: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen 160 mg

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:06.665179 · Updated: 2026-03-14T23:04:35.063520