FDA Label for Multi-symptom Cold Relief

Other

Drug Facts

Otc - Active Ingredient

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Otc - Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Indications & Usage

Uses

Temporarily relieves these symptoms due to the common cold

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

Temporarily reduces fever.

Warnings

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.

Otc - Do Not Use

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.

Otc - Ask Doctor

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

When using this product do not exceed recommended dosage.

Otc - Stop Use

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

Directions

• do not take more than directed

​Adults and children: (12 years and over)

• take 2 caplets every 4 hours
• not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Other Safety Information

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive Ingredient

Inactive ingredients corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone,silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Otc - Questions

Questions or comments? 1-800-869-6970

Package Label.Principal Display Panel

Multi-Symptom Cold Relief™

Pull to Open

Tire Para Abrir

Acetaminophen / Acetaminofeno 325 mg

Dextromethorphan HBr / Hidrobromuro de dextrometorfano 10 mg

Guaifenesin / Guaifenesina 100 mg

Phenylephrine HCl / Hidrocloruro de fenilefrina 5 mg

Green Guard®

Pain reliever/Fever reducer

Multi-Symptom Relief

Alivia el dolor/Reduce la fiebre

Alivia multisintomas

Distributed by Green Guard®

St Louis, MO 63045

40 Packets of 2 Caplets

80 Caplets

Order #2580