Acetaminophen Elxir

Acetaminophen Elxir
SPL v3
SPL
SPL Set ID cf2dd95d-afea-462d-9dba-a46a68bf67e6
Route
ORAL
Published
Effective Date 2022-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Glycerin Polyethylene Glycol 400 Water Sodium Citrate Saccharin Sodium Sorbitol Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-05-18
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 42229-5

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

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product: Do not exceed recommended dose

Section 50568-5

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

Section 50569-3

Ask a doctor before use if your child has

  • liver disease
  • is on a sodium-restricted diet.
Section 51945-4

Section 53414-9

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

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
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.

Other Information
  • Store at room temperature 15°-30° C (59°-86°F)
  • Protect from Freezing. 
  • Protect from Light.
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.

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.

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

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.

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 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product: Do not exceed recommended dose

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if your child has

  • liver disease
  • is on a sodium-restricted diet.
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Pain Reliever/Fever Reducer

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
Liver Warning (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.

Other Information (Other information)
  • Store at room temperature 15°-30° C (59°-86°F)
  • Protect from Freezing. 
  • Protect from Light.
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.

Sore Throat Warning: (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.

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

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.

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: 2026-02-15T12:00:22.767795 · Updated: 2026-03-14T23:00:46.071932