Cold by Chalkboard Health Inc / LNK International, Inc. Fluent 44-730-Delisted

Cold by

Drug Labeling and Warnings

Cold 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]

COLD- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled 
Chalkboard Health Inc

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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Fluent 44-730-Delisted

Active ingredients (in each liquid-filled capsule)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • nasal congestion
    • headache
    • fever
    • minor aches and pains
    • cough due to minor throat and bronchial irritation

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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema 
  • heart disease
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. 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
  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 4 hours
  • children under 12 years: ask a doctor

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from light, heat and moisture
  • see end flap for expiration date and lot number

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC: 79395-730-08

ºFluent™

Multi-Symptom
Cold DAY

Acetaminophen
Dextromethorphan HBr
Phenylephrine HCI

Pain Reliever/Fever Reducer
Cough Suppressant
Nasal Decongestant

24 Liquid-Filled Capsules/Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF
BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS
OF TAMPERING

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

Product of Dubai
Packaged and Quality
Assured in the USA
50844 ORG012073008

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Fluent 44-730

Fluent 44-730

COLD 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79395-730
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colororange (clear red orange) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code 730
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79395-730-082 in 1 CARTON08/20/202006/14/2023
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/20/202006/14/2023
Labeler - Chalkboard Health Inc (117569507)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(79395-730)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(79395-730)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(79395-730)

Revised: 6/2023
 

Trademark Results [Cold]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COLD
COLD
97615326 not registered Live/Pending
Cold Climate, PBC
2022-09-30
COLD
COLD
97461587 not registered Live/Pending
Cold Climate, PBC
2022-06-16
COLD
COLD
90453456 not registered Live/Pending
Noel Clayton C
2021-01-07
COLD
COLD
90453456 not registered Live/Pending
Noel Clinton E Jr.
2021-01-07
COLD
COLD
88924714 not registered Live/Pending
Usa Cool Cold Chain Co., Ltd
2020-05-20
COLD
COLD
88921260 not registered Live/Pending
Usa Cool Cold Chain Co., Ltd
2020-05-18
COLD
COLD
88917797 not registered Live/Pending
Usa Cool Cold Chain Co., Ltd
2020-05-15
COLD
COLD
88769875 not registered Live/Pending
Cold Enterprises
2020-01-22
COLD
COLD
88765387 not registered Live/Pending
Usa Cool Cold Chain Co., Ltd
2020-01-19
COLD
COLD
88369695 not registered Dead/Abandoned
British American Tobacco (Brands) Limited
2019-04-03
COLD
COLD
88340195 not registered Live/Pending
Bonneville International Corporation
2019-03-14
COLD
COLD
77817105 3894965 Live/Registered
VEOLIA WATER TECHNOLOGIES, INC.
2009-09-01

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