GREEN GUARD COUGH AND COLD RELIEF - acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet, film coated 
Unifirst First Aid Corporation

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425R Green Guard Cough and Cold Relief

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 8 tablets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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.
• with any other product containing any of the above active 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)
• chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• avoid alcoholic drinks
• be careful driving a motor vehicle or operating machinery

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

croscarmellose sodium*, hypromellose*, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, povidone*, sodium starch glycolate*, starch, stearic acid.

*may contain

Questions or comments? 1-800-869-6970

425R Green Guard Cough and Cold Relief Label

Cough and Cold 2 relief
Pain reliever/Fever reducer
Multi-Symptom Relief
See new warnings information
Green Guard®
Pull Out
Tabletas para el alivio la y el resfriado
Acetaminophen/Acetamonofeno 325mg
Dextromethorphan HBr/Hidrobromuro de dextrometorfano 15mg
Guaifenesin/Guaifenesina 200mg
Phenylephrine HCl/Hidrocloruro de fenilefrina 5mg
125 Packets of 2 Tablets
250 Tablets
Order #2217
Distributed by Green Guard®, St Louis, MO 63045

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

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 47682-005 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   CROSCARMELLOSE SODIUM   HYPROMELLOSES   POLYETHYLENE GLYCOL   STARCH, CORN   STEARIC ACID

Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code AZ;273 Contains

Packaging # NDC Package Description Multilevel Packaging 1 47682-005-33 50 PACKET In 1 BOX, UNIT-DOSE contains a PACKET (47682-005-99) 1 47682-005-99 2 TABLET In 1 PACKET This package is contained within the BOX, UNIT-DOSE (47682-005-33) 2 47682-005-48 125 PACKET In 1 BOX, UNIT-DOSE contains a PACKET (47682-005-99) 2 47682-005-99 2 TABLET In 1 PACKET This package is contained within the BOX, UNIT-DOSE (47682-005-48)

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)

Revised: 06/2010Unifirst First Aid Corporation