ACETAMINOPHEN (RED)- acetaminophen (red) - acetaminophen capsule liquid filled capsule, liquid filled 
One2zee Limited Liability Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACETAMINOPHEN

Drug Facts

Active ingredient (in each capsule)

Acetaminophen 325 mg

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. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours
• 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 every day while using this product

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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Do not take more than directed
(seeOverdose warning)

 adults and children 12 years and over
  • take 2 softgels every 4 to 6 hours while symptoms last
  • do not take more than 10 softgels in 24 hours
  • do not use for more than 10 days unless directed by a doctor
 children 6-11 years
  • take 1 softgel every 4 to 6 hours while symptoms last
  • do not take more than 5 softgels in 24 hours
  • do not use for more than 5 days unless directed by a doctor
 children under 6 years ask a doctor

Other Information

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

FD&C red #40, gelatin, sorbitol, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, titanium dioxide, purified water

PRINCIPAL DISPLAY PANEL - Shipping Label

ACETAMINOPHEN CAPSULES, 325 mg

Quantity : 48 Bags of 300 Capsules each
NDC. No : 55629-718-01

Important:

1. Inspect immediately upon receipt

2. This is bulk shipment intended for further processing only
3. Store at controlled temperature of 59°F to 86°F (15°C to 30°C) avoid high humidity and excessive heat above 104°F (40°C)

PRINCIPAL DISPLAY PANEL - Shipping Label

ACETAMINOPHEN (RED) 
acetaminophen (red) - acetaminophen capsule liquid filled capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-718
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE K30 (UNII: U725QWY32X)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScoreno score
Shapecapsule (Oblong) Size20mm
FlavorImprint Code 718
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55629-718-0148 in 1 BOX02/25/2019
1NDC:55629-718-02300 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/25/2019
Labeler - One2zee Limited Liability Company (078656111)
Registrant - One2zee Limited Liability Company (078656111)
Establishment
NameAddressID/FEIBusiness Operations
Medgel Private Limited677385498manufacture(55629-718) , analysis(55629-718)

Revised: 2/2019
Document Id: 47e1af5e-e6b7-4543-829d-ca1605319872
Set id: b2c38aaa-c383-49f8-8151-fa0bf5d10ba3
Version: 1
Effective Time: 20190222
 
One2zee Limited Liability Company