HANDY SOLUTIONS COLD RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
Navajo Manufacturing Company Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Handy Solutions Cold Relief
Active ingredient (in each tablet)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Uses
Temporarily:
• relieves nasal congestion associated with sinusitis
• relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• relieves sinus congestion and pressure, helps decongest sinus openings and passages
• restores free breathing
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
• temporarily suppresses cough due to minor throat and bronchial irritation associated with cold or inhaled irritants
Temporarily relieves minor aches, pains and fever associated with:
• headache • backache • common cold • muscular aches
• toothache • menstrual cramps
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
• 3 or more alcoholic drinks every day while using this product
Do not use:
• with any other product containing acetaminophen. This will provide more than the recommended dose (overdose) of acetaminophen and could
cause serious health concerns
• more than the recommended dose
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or
pharmacist before taking this product.
Stop use and ask a doctor if:
• symptoms do not improve
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever
• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Ask a doctor before use if you have:
• heart disease • high blood pressure
• thyroid disease • diabetes
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
Directions
Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 hours as needed; do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years of age: consult a doctor
Other information
- Tamper evident. Do not use if packet is torn, cut or opened.
- Store at controlled room temperatures 15° to 30°C (59° to 86°F)
- Avoid excessive heat and humidity.
| HANDY SOLUTIONS COLD RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet |
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| Labeler - Navajo Manufacturing Company Inc. (091917799) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ultra Seal Corporation | 085752004 | pack(67751-177) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Navajo Manufacturing Company Inc. | 136941411 | repack(67751-177) , relabel(67751-177) | |