CAROLINA CRUD CRUSHER- dextromethorphan hbr, guaifenesin syrup

Carolina Crud Crusher by

Drug Labeling and Warnings

Carolina Crud Crusher by is a Otc medication manufactured, distributed, or labeled by Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each teaspoonful (5 mL))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purposes

Cough suppressant

Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to:
• drain bronchial tubes
• make coughs more productive
• rid bronchial passageways of bothersome mucus
• temporarily relieve cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

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 1 week, comes back, or occurs with a fever, rash, or headache that lasts. 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.

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

Directions

• take every 4 hours
• do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 2 teaspoonfuls (10 mL)
• children 6 to under 12 years: 1 teaspoonful (5 mL)
• children 2 to under 6 years: 1/2 teaspoonful (2-1/2 mL)
• children under 2 years: ask a doctor

Other information

• store at 20º C to 25º C (68º F 77º F)
• do not refrigerate
• to report serious side effects due to the use of this product call (515) 276-1586

Inactive ingredients

citric acid (anhydrous), FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

PRINCIPAL DISPLAY PANEL

Carolina Crud Crusher

Expectorant DM Tasty Cough Syrup

• Loosens & Relieves Chest Congestion
• Cough Suppressant

INGREDIENTS AND APPEARANCE

CAROLINA CRUD CRUSHER 
dextromethorphan hbr, guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11383-311
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	red (Red to Orange-red)	Score
Shape		Size
Flavor	PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11383-311-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2022

Labeler - Weeks & Leo Co., Inc. (005290028)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(11383-311)