Acetaminophen
FDA Label NDC 17856-5403

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 17856-5403). 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)

→ 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.

→ Directions

→ Other Information

→ Inactive Ingredients:

→ Questions Or Comments?

→ Principal Display Panel

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:

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