ACETAMINOPHEN ORAL SOLUTION- acetaminophen 160mg/5ml solution

Acetaminophen Oral Solution by

Drug Labeling and Warnings

Acetaminophen Oral Solution by is a Otc medication manufactured, distributed, or labeled by Aldama Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL-teaspoonful)

Acetaminophen 160mg

Purpose

Pain reliever/fever reducer

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

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.

DO NOT USE

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.

ASK DOCTOR

Ask a doctor before use if your childhas liver disease

ASK DOCTOR/PHARMACIST

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

WHEN USING

When using this product do not exceed recommended dose

STOP USE

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.

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

ask a health professional before use

DOSAGE & 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	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

Inactive Ingredient

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

QUESTIONS

Question or Comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN ORAL SOLUTION 
acetaminophen 160mg/5ml solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73564-816
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYETHYLENE GLYCOL 350 (UNII: ZBR3T82M2V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73564-816-16	1 in 1 BOX	01/01/2026
1		473 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/01/2026

Labeler - Aldama Pharmaceuticals, Inc (119484030)

Establishment
Name	Address	ID/FEI	Business Operations
Aldama Pharmaceuticals, Inc		119484030	manufacture(73564-816)