GREEN GUARD COUGH AND COLD RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

Green Guard Cough and Cold Relief by

Drug Labeling and Warnings

Green Guard Cough and Cold Relief by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation, Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15mg

Guaifenesin 200mg

Phenylephrine Hydrochloride 5mg

Purposes

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Temporarily relieves these cold symptoms

• cough
• sore throat
• minor aches and pains
• headache
• nasal congestion
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Temporarily reduces fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients
• 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

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistant or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

When using this product

• do not use more than directed

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain or nasal congestion gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
• you get nervous, dizzy or sleepless
• cough comes back or occurs with 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children: (12 years and older)

Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

• store at room temperature 59°-86°F (15°-30°C)
• avoid excessive heat and humidity
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide* sodium starch glycolate, starch, stearic acid

*May contain

Questions or comments?

1-800-869-6970

Green Guard Cough and Cold Relief Label

Cough and Cold 2 relief

Tabletas para el alivio la y el resfriado
Pull To Open

Tire Para Abrir

Acetaminophen/Acetamonofeno 325mg
Dextromethorphan HBr/Hidrobromuro de dextrometorfano 15mg
Guaifenesin/Guaifenesina 200mg
Phenylephrine HCl/Hidrocloruro de fenilefrina 5mg

Green Guard®

Pain reliever/Fever reducer

Nasal decongestant
50 Packets of 2 Tablets
100 Tablets
Order #2216
Distributed by Green Guard®, St Louis, MO 63045

An FDA Regulated Facility

Private Label Distributors Label

INGREDIENTS AND APPEARANCE

GREEN GUARD COUGH AND COLD RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	FR;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-006-33	50 in 1 BOX	12/30/2008
1	NDC: 47682-006-99	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-006-48	125 in 1 BOX	12/30/2008
2	NDC: 47682-006-99	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-006-99	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
ULtratab Laboratories, Inc.		151051757	manufacture(47682-006)