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Handy Solutions Cold Relief

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-177

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.

Handy Solutions Cold Relief

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain Reliever/Fever Reducer

Cough Suppressant

Expectorant

Decongestant

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)

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 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.

Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

Call 1-800-525-5097

Package Labeling:

HANDY SOLUTIONS COLD RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-177
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize12mm
FlavorImprint CodeFR12
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-177-032 TABLET in 1 POUCH
2NDC:67751-177-041 POUCH in 1 CARTON
22 TABLET in 1 POUCH
3NDC:67751-177-053 POUCH in 1 CARTON
32 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/22/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004pack(67751-177)
Establishment
NameAddressID/FEIOperations
Navajo Manufacturing Company Inc.136941411repack(67751-177), relabel(67751-177)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(67751-177)

 
Navajo Manufacturing Company Inc.

Medically reviewed on Oct 11, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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