KROGER COUGH COLD AND FLU- choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid 
THE KROGER CO

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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Kroger Cough Cold & Flu

Drug Facts

Active ingredients

(in each 30 mL (2TBSP))

Choline Salicylate (NSAID)* 870 mg

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Temporarily relieves these common cold and flu symptoms:

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product do not use more than directed

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Edetate sodium, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Questions or comments?

1-800-632-6900

KROGER COUGH COLD & FLU 8 fl oz (234 mL) Bottle Label

Kroger Cough Cold Label1

Kroger Cough Cold Label2

KROGER COUGH COLD AND FLU 
choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-771
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-771-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/07/2016
Labeler - THE KROGER CO (006999528)

Revised: 6/2016
Document Id: 36817db5-4b20-7288-e054-00144ff88e88
Set id: 36817db5-4b1f-7288-e054-00144ff88e88
Version: 1
Effective Time: 20160630
 
THE KROGER CO