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PhytoRelief CC HERBAL by Gelnova Laboratories (India) Private Limited

Dosage form: lozenge
Ingredients: MENTHOL 7mg
Labeler: Gelnova Laboratories (India) Private Limited
NDC Code: 71123-001

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.

Drug Facts

Active Ingredient

Menthol 7mg

Purpose

Cough Suppressant/Oral Anesthetic

Uses

temporarily relieves •cough due to minor and bronchial irritation occurring with a cold or inhaled irritants •occasional minor irritation and sore throat

Warnings

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

Ask a doctor before use if you have

•persistent or chronic cough such as occurs with smoking, asthma, or emphysema •cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

•cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. •sore throat is severe or irritation, pain, or redness lasts or worsens •sore mouth does not improve in 7 days.

Keep out of reach of children

if pregnant or breast feeding ask a Health Professional before using

Directions

• Adults and children 6 years and older: Take 1 lozenge slowly in the mouth. May be repeated every hour as needed or as directed by a doctor • Children under 6 years: ask a doctor • Do not chew, Suck slowly for better result

Other Information

Store in a cool, dry place. Protect from direct heat and sunlight as it may soften the lozenges. If lozenges are found in soft condition, refrigerate for 15 minutes before consuming. • Always keep the strip facing product down and printed side upward.

Inactive Ingredients

Eucalyptus oil, Gelatin, Ginger Extract, Glycerin, Polysorbate 80, Purified Water, Pomegranate Extract, Soy Lecithin, Spearmint, Sodium Benzoate, Sucralose, Turmeric Extract.

Questions or comments?

Contact: 1-281-208-7518

Package Label

PHYTORELIEF CC  HERBAL
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71123-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL7 mg
Inactive Ingredients
Ingredient NameStrength
POMEGRANATE 
GELATIN 
GINGER 
EUCALYPTUS OIL 
LECITHIN, SOYBEAN 
GLYCERIN 
POLYSORBATE 80 
WATER 
SPEARMINT 
TURMERIC 
SODIUM BENZOATE 
SUCRALOSE 
Product Characteristics
Colorbrown (DARK BROWN) Scoreno score
ShapeRECTANGLE (Lozenge) Size14mm
FlavorMINT (Mint, Pomegranate and Ginger) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:71123-001-1010 LOZENGE in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/04/2017
Labeler - Gelnova Laboratories (India) Private Limited (920504987)

 
Gelnova Laboratories (India) Private Limited

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Medically reviewed on Jan 20, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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