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Green Guard Cold Relief


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg


OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


INDICATIONS & USAGE SECTION

Uses

Temporarily relieves these symptoms due to the common cold

Temporarily reduces fever.

  • 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

WARNINGS SECTION

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.

  • 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

OTC - DO NOT USE SECTION

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 SECTION

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 SECTION

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


OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage.


OTC - STOP USE SECTION

Stop use and ask a doctor if

These could be signs of a serious condition.

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

Directions

​Adults and children: (12 years and over)

Children under 12 years: ask a doctor

  • do not take more than directed

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 SECTION

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 SECTION

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