HISTIACIL COUGH- dextromethorphan hydrobromide and guaifenesin capsule

Histiacil Cough by

Drug Labeling and Warnings

Histiacil Cough by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS (in each softgel)	PURPOSE
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant

Uses

helps loosen phlegm (mucus)

helps thin bronchial secretions to make coughs more productive

Warnings

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.

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, recurs, or is accompained by fever, rash, or persistent headache. 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

Overdose warning

In case of 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 - See Overdose warning

Do not use for more than 7 days.

Do not take more than 6 doses in 24 hours

• Adults and children 12 years of age & over: Take 1 softgel every 4 hours with a full glass of water while symptoms persist
• Children under 12 years of age: Do not use

Other Information

Store at room temperature between 20-25°C (68-77°F)

Avoid excessive heat and humidity

Inactive Ingredients

FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

Questions or comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)

SPL UNCLASSIFIED SECTION

Exclusively distributed by:
OPMX
Chula Vista, CA 91910

PRINCIPAL DISPLAY PANEL - 20 Softgel Blister Pack Box

NDC: 69729-000-00

Histiacil NF

Dextromethorphan HBr
Guaifenesin

Cough

Expectorant & Cough Supressant

• Controls cough
• Thins & loosens mucus
• Easy to swallow

20 Softgels Box

INGREDIENTS AND APPEARANCE

HISTIACIL COUGH 
dextromethorphan hydrobromide and guaifenesin capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-108
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	781
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-108-20	2 in 1 BOX	03/01/2022
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/01/2022

Labeler - OPMX LLC (029918743)

Registrant - Strive Pharmaceuticals Inc. (474844049)