NATURAL HERB COUGH DROP- menthol lozenge 
P.S.W. 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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Drug Facts

Active Ingredient (in each drop)

Menthol, 3mg

Purposes

Cough suppressant, Oral pain reliever

Uses

temporarily relieves

  • Cough due to minor throat and bronchial irritation with common cold or inhaled irritants
  • ocasional minor irritation or sore throat

Warnings

Sore throat warnings:

  • if sore throat is severe persists for more than 2 days is acompained or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.These may be serious.

Do not use in children under 6 years of age unless directed by a doctor.

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of serious condition
  • sore mouth does not improve in 7 days
  • irritation pain, or redness persists or worsens

Keep out of reach of children.

Directions

  • adults and children 6 years and older: dissolve 2 drops slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
  • children under 6 years: ask a doctor

Inactive Ingredients

Lotus Root, Bitter Apricot Seed, Fragrant Solomonseal Rhizome, Dwarf Lilyturf Tuber, Fortune's Drynaria Rhizome, Liquorice Root, Chinese Gall, Cinnamon, Peppermint Oil.

Principal Display Panel

TAKABB

Natural Herb Cough Drops

Cough Suppressant Throat Drops

Net Wt 0.10 oz. (30 drops)

PRODUCT OF THAILAND

TAKABB

Natural Herb Cough Drops

Cough Suppressant Throat Drops

Menthol Flavor

Net 0.32 oz. (90 drops)

PRODUCT OF THAILAND

Label 1Label 2

NATURAL HERB  COUGH DROP
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57373-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 mg
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYGONATUM ODORATUM WHOLE (UNII: C4O9177MBP)  
PRUNUS ARMENIACA WHOLE (UNII: 10TCS27K2T)  
NELUMBO NUCIFERA WHOLE (UNII: 622D93A1R1)  
LICORICE (UNII: 61ZBX54883)  
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
CINNAMON (UNII: 5S29HWU6QB)  
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
RHUS CHINENSIS WHOLE (UNII: J6BED8187F)  
Product Characteristics
Colorbrown (GOLDEN BROWN) Scoreno score
ShapeROUND (NO) Size5mm
FlavorMENTHOL (HERBAL MENTHOL) Imprint Code NO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57373-105-0130 in 1 PACKAGE; Type 0: Not a Combination Product04/02/201312/31/2016
2NDC:57373-105-0290 in 1 PACKAGE; Type 0: Not a Combination Product04/02/201312/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/02/201312/31/2016
Labeler - P.S.W. INC. (802789420)

Revised: 12/2016
 
P.S.W. INC.