CRANE SAFETY COLD RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

Crane Safety Cold Relief by

Drug Labeling and Warnings

Crane Safety Cold Relief by is a Otc medication manufactured, distributed, or labeled by Crane Safety LLC, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15mg

Guaifenesin 200mg

Phenylephrine Hydrochloride 5mg

Purpose

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Temporarily relieves these cold symptoms

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

Temporarily reduces fever.

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.

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.

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged 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

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

When using this product

• do not use more than directed

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain or nasal congestion gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
• you get nervous, dizzy or sleepless
• cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

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 and older)

Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

• store at room temperature 59°-86°F (15°-30°C)
• avoid excessive heat and humidity
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid

*may contain

Questions or comments?

877.506.4291

Crane Safety Cold Relief Label

This package is For Households without Young Children.

Cold Relief

Multi-Symptom Relief

CRANE Safety®

Pull to Open

Aches, Fever

Acetaminophen 325 MG

Coughs

Dextromethorphan HBR 15 MG

Chest Congestion

Guaifenesin 200 MG

Nasal Congestion

Phenylephrine HCl 5 MG

100 Tablets

Tamper Evident

Sealed Packets

INGREDIENTS AND APPEARANCE

CRANE SAFETY COLD RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73408-159(NDC:47682-159)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73408-159-33	50 in 1 BOX	01/17/2020
1		2 in 1 PACKET; 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	01/17/2020

Labeler - Crane Safety LLC (080998015)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(73408-159) , repack(73408-159)