HANDY SOLUTIONS COLD RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

Handy Solutions Cold Relief by

Drug Labeling and Warnings

Handy Solutions Cold Relief by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc., Ultra Seal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

HANDY SOLUTIONS COLD RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-177
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	FR12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-177-03	2 in 1 POUCH; Type 0: Not a Combination Product	10/22/2016
2	NDC: 67751-177-04	1 in 1 CARTON	10/22/2016
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 67751-177-05	3 in 1 CARTON	10/22/2016
3		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/22/2016

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)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(67751-177)