Fever and Pain by Chalkboard Health Inc / LNK International, Inc. Pain Reliever

Fever and Pain by

Drug Labeling and Warnings

Fever and Pain by is a Otc medication manufactured, distributed, or labeled by Chalkboard Health Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FEVER AND PAIN- acetaminophen tablet, film coated 
Chalkboard Health Inc

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Pain Reliever

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • the common cold
  • muscular aches
  • backache
  • toothache
  • premenstrual and menstrual cramps
  • minor pain of arthritis
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• 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.

Do not use

• if you are allergic to acetaminophen or any of the inactive ingredients in this product
• 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 a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• new symptoms occur
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
  
• redness or swelling is present

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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
  
• adults and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• see end flap for expiration date and lot number
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

 1-800-426-9391

Principal Display Panel

NDC: 79395-175-15

Fluent™

Extra Strength
Fever + Pain
Acetaminophen 500 mg
Pain Reliever
Fever Reducer

Contains No Aspirin

50 Caplets/Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed By:
Chalkboard Health, Inc.
Princeton, NJ 08540
getfluenthealth.com
50844 ORG061717515

44-175

FEVER AND PAIN 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79395-175
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;175
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79395-175-15	1 in 1 CARTON	08/20/2020	12/20/2023
1		50 in 1 BOTTLE, PLASTIC; 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	08/20/2020	12/20/2023

Labeler - Chalkboard Health Inc (117569507)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(79395-175)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(79395-175)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(79395-175)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	manufacture(79395-175)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(79395-175)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117597853	pack(79395-175)

Revised: 12/2023

Document Id: 6348f706-74e6-450e-b0d3-235df67eab8f

34390-5

Set id: 70611505-1e1e-4ab7-8052-2b275b1c3249

Version: 5

Effective Time: 20231221