Acetaminophen Oral Solution

Manufacturer
Aldama Pharmaceuticals, Inc
Effective date
2026-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-03 18:04:14

Label at a glance#

ProductAcetaminophen Oral Solution
Active ingredientACETAMINOPHEN
Label structure16 sections

Indications and 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

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL-teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your childhas liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose

OTC - STOP USE SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

DOSAGE & ADMINISTRATION SECTION

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)

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredient

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

OTC - QUESTIONS SECTION

Question or Comments?

call 305-592-9216 or info@aldamapharm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN2
307675acetaminophen 32 MG/ML Oral SolutionSCD2
307675acetaminophen 160 MG per 5 ML Oral SolutionSY2
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY2
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY2
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY2
307675APAP 32 MG/ML Oral SolutionSY2

DailyMed Product Concepts#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73564-81673564-816-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-18full-release2026-06-01 01:34:10

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
58b4e07b-a90b-c4ed-e063-6394a90a932c1a07fd53-e968-444e-b1f2-6e1f31fd4eee2026-08-10WarningsExact identifier
spl set id: 1a07fd53-e968-444e-b1f2-6e1f31fd4eee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.