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
occasional minor irritation or sore throat

Warnings

Sore throat warnings:

if sore throat is severe persists for more than 2 days is accompained 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 a serious condition.
sore mouth does not improve in 7 days
irritation pain, or redness persists or worsens

Keep out of reach of children.

Enter section text here

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, Figwort Root, Liquorice Root, Chinese Gall, Sugar, Natural Flavour, Peppermint Oil, Stevia, Corn Starch, Calcium Carbonate, Titanium Dioxide, Palm Wax.

Principal Display Panel

TAKABB

Fights Coughs Naturally

Soothes Sore Throats

Natural Chinese Herb

Mint

Menthol

Flavor

Natural Herb

Cough Drops

Cough Suppressant Throat Drops

Net 0.10 oz. (30 drops)

PRODUCT OF THAILAND

TAKABB

Fights Coughs Naturally

Soothes Sore Throats

Natural Chinese Herb

Mint

Menthol

Flavor

Natural Herb

Cough Drops

Cough Suppressant Throat Drops

Net 0.32 oz. (90 drops)

PRODUCT OF THAILAND

Label 1 Label 2

NATURAL HERB COUGH DROP
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57373-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 mg

Ingredient Name	Strength
Inactive Ingredients
LICORICE (UNII: 61ZBX54883)
RHUS CHINENSIS ROOT (UNII: 7363Z73686)
SUCROSE (UNII: C151H8M554)
PEPPERMINT OIL (UNII: AV092KU4JH)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
STARCH, CORN (UNII: O8232NY3SJ)
CALCIUM CARBONATE (UNII: H0G9379FGK)
NELUMBO NUCIFERA ROOT (UNII: F60P1G6K6N)
PRUNUS ARMENIACA WHOLE (UNII: 10TCS27K2T)
POLYGONATUM ODORATUM WHOLE (UNII: C4O9177MBP)
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
SCROPHULARIA NODOSA ROOT (UNII: 3R84T369J0)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	blue (blue)	Score	no score
Shape	ROUND (na)	Size	5mm
Flavor	MINT (mint)	Imprint Code	na
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57373-101-01	30 in 1 PACKAGE; Type 0: Not a Combination Product	03/18/2013	12/31/2016
2	NDC:57373-101-02	90 in 1 PACKAGE; Type 0: Not a Combination Product	03/18/2013	12/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/18/2013	12/31/2016

Labeler - P.S.W. INC. (802789420)

Revised: 12/2016

Document Id: 6433c0fa-383e-4d24-8ae3-39839fc3d9aa

Set id: 3734ea93-2d66-434a-acba-3cfcf7f0ccf3

Version: 2

Effective Time: 20161227

P.S.W. INC.