Label: ACETAMINOPHEN ORAL SOLUTION- acetaminophen 160mg/5ml solution
- NDC Code(s): 73564-816-16
- Packager: Aldama Pharmaceuticals, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 18, 2026
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL-teaspoonful)
- Purpose
- Uses
-
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- Keep out of reach of children.
- If pregnant or breast-feeding
-
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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN ORAL SOLUTION
acetaminophen 160mg/5ml solutionProduct 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)

