Acetaminophen
FDA Label NDC 17856-0182

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Acetaminophen (NDC 17856-0182). 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, liver warning, sore throat warning:, do not use, otc - ask doctor, otc - ask doctor/pharmacist, 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.

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

Otc - Ask Doctor

Ask a doctor before use if your child has

  • liver disease
  • is on a sodium-restricted diet.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Otc - When Using

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

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.

Other

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive Ingredients:

Bubble Gum Flavor, Citric Acid, FD C RED #40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

* Please review the disclaimer below.