ACETAMINOPHEN- acetaminophen liquid 
Proficient Rx LP

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Acetaminophen

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Acetaminophen, USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

headache
muscular aches
backache
arthritis
the common cold
toothache
menstrual cramps
reduces fever

Warnings

Liver Warning

This product contains acetaminophen.

Severe liver damage may occur if you take:

more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this 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.

Ask a doctor before use

if you have health issues especially liver disease.

Ask a doctor or pharmacist before use

if you are taking other drugs, including the blood thinner warfarin.

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.

for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop use and ask a doctor if

new symptoms occur such as rash, hives, itching or hoarseness
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
symptoms do not improve

These could be signs of a serious condition.

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 contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dosage.

Overdose Warnings

Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.

adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Other information

If dispensed, dispense in a tight, light resistant container with a child-resistant cap.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Inactive ingredients

Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate,Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.

Questions?

You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-7294 or FDA at 1-800-FDA-1088.

PRINCIPAL DISPLAY PANEL – 4 fl. oz. (118 mL) Bottle Label

NDC 71205-730-04

Acetaminophen
Liquid
160 mg/5 mL

Pain Reliever / Fever Reducer
Sugar Free / Alcohol Free
Aspirin Free

CHERRY FLAVOR

4 fl. oz. (118 mL)

71205-730-04
ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-730(NDC:69367-323)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-730-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01305/05/2021
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(71205-730)

Revised: 12/2023
Document Id: 8bf62cab-8919-4e74-84aa-dc987ca3f431
Set id: 402c8563-b14b-453f-80bc-4275f1c73702
Version: 2
Effective Time: 20231201
 
Proficient Rx LP