Acetaminophen Oral Solution

SPL v1

SPL

SPL Set ID 1a07fd53-e968-444e-b1f2-6e1f31fd4eee

Route

ORAL

Published

Effective Date 2026-01-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Water Sucralose Anhydrous Citric Acid Polyethylene Glycol 350 Propylene Glycol Methylparaben Propylparaben Sodium Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

Acetaminophen 160mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Dosage and Administration

Directions

find dose in chart below
if possible, use weight to dose, otherwise use age
dosage may be repeated every 4 hours, or as directed by a doctor
do not give more than 5 doses in 24 hours

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Age

(years)

Under 2

2 to 3

4 to 5

6 to 8

9 to 10

12 to

adult

Dosage

teaspoonful (tsp)

consult Physician

1 tsp

(5 ml)

1 1/2 tsp

(7.5ml)

2 tsp

(10 ml)

2 1/2 tsp

(12.5ml)

3 tsp

(15 ml)

4 tsp

(20 ml)

Description

Acetaminophen 160mg

Uses

Temporarily relieves 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 50566-9

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults 5 days
pain gets worse or lasts more than 5 days in children under 12 years
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.

Section 50567-7

When using this product do not exceed recommended dose

Section 50568-5

Ask a doctor before use if you have taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if your childhas liver disease

Section 50570-1

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.

Section 51727-6

Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4

Section 53413-1

Question or Comments?

call 305-592-9216 or [email protected]

Section 60561-8

Other information

for institutional or pharmacy use only
store at room temperature between 15-30°C (59-86°F)
do not freezing
protect from light
TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if:

if adults 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 the product.

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children.

In case of overdose, get medical help or conbtact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms

Active Ingredient (in Each 5 Ml Teaspoonful)

Acetaminophen 160mg

Structured Label Content

Uses

Temporarily relieves 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

Dosage and Administration (34068-7)

Directions

find dose in chart below
if possible, use weight to dose, otherwise use age
dosage may be repeated every 4 hours, or as directed by a doctor
do not give more than 5 doses in 24 hours

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Weight

(lbs)

Age

(years)

Under 2

2 to 3

4 to 5

6 to 8

9 to 10

12 to

adult

Dosage

teaspoonful (tsp)

consult Physician

1 tsp

(5 ml)

1 1/2 tsp

(7.5ml)

2 tsp

(10 ml)

2 1/2 tsp

(12.5ml)

3 tsp

(15 ml)

4 tsp

(20 ml)

Section 50566-9 (50566-9)

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults 5 days
pain gets worse or lasts more than 5 days in children under 12 years
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.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50568-5 (50568-5)

Ask a doctor before use if you have taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if your childhas liver disease

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question or Comments?

call 305-592-9216 or [email protected]

Section 60561-8 (60561-8)

Other information

for institutional or pharmacy use only
store at room temperature between 15-30°C (59-86°F)
do not freezing
protect from light
TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing

Purpose

Pain reliever/fever reducer

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if:

if adults 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 the product.

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or conbtact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL-teaspoonful))

Acetaminophen 160mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves 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", "34068-7": "Directions find dose in chart below if possible, use weight to dose, otherwise use age dosage may be repeated every 4 hours, or as directed by a doctor do not give more than 5 doses in 24 hours Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult Dosage teaspoonful (tsp) consult Physician 1 tsp (5 ml) 1 1/2 tsp (7.5ml) 2 tsp (10 ml) 2 1/2 tsp (12.5ml) 3 tsp (15 ml) 4 tsp (20 ml)", "50566-9": "Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults 5 days pain gets worse or lasts more than 5 days in children under 12 years 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.", "50567-7": "When using this product do not exceed recommended dose", "50568-5": "Ask a doctor before use if you have taking the blood thinning drug warfarin.", "50569-3": "Ask a doctor before use if your child has liver disease", "50570-1": "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.", "51727-6": "Inactive Ingredient artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose", "53413-1": "Question or Comments? call 305-592-9216 or info@aldamapharm.com", "60561-8": "Other information for institutional or pharmacy use only store at room temperature between 15-30°C (59-86°F) do not freezing protect from light TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing", "Purpose": "Pain reliever/fever reducer", "Warnings": "Liver warning This product contains acetaminophen. Severe liver damage may occur if: if adults 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 the product. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.", "If pregnant or breast-feeding": "ask a health professional before use", "Keep out of reach of children.": "In case of overdose, get medical help or conbtact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms", "Active ingredient (in each 5 mL-teaspoonful)": "Acetaminophen 160mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:19.357491 · Updated: 2026-03-14T23:12:31.383435