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NITECLEAR COLD AND FLU RELIEF

Medically reviewed on January 1, 2017

Dosage form: solution
Ingredients: CHOLINE SALICYLATE 870mg in 1mL, DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 1mL
Labeler: GM Pharmaceuticals, INC
NDC Code: 58809-514

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.

NITECLEAR COLD AND FLU RELIEF

NiteClear® Cold & Flu Relief

(choline salicylate, diphenhydramine hcI, phenylephrine hcl), solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

 

Choline Salicylate (NSAID)* 870 mg

Diphenhydramine HCI 50mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

nonsteroidal anti-inflammatory drug*

Uses

▪temporarily relieves these common cold and flu symptoms:

▪ nasal congestion

▪ minor aches and pains

▪ runny nose

▪ sneezing

▪ watery eyes

▪ sore throat

▪ headache

▪ temporarily reduces fever

Warnings

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

▪ hives

▪ rash

▪ shock

▪ skin reddening

▪ facial swelling

▪ asthma (wheezing)

Stomach bleeding warnings

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

▪ are age 60 or older

▪ have had stomach ulcers or bleeding problems

▪ take a blood thinning (anticoagulant) or steroid drug

▪ take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

▪ have 3 or more alcoholic drinks every day while using this product

▪ take more or for a longer time than directed

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

▪ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever / fever reducer.

▪ with any other drug containing diphenhydramine, even one used on the skin

▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 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.

▪ in children under 12 years of age

Ask a doctor before use if

▪ stomach bleeding warning applies to you

▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems

▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes, thyroid disease, or glaucoma

▪ you have a cough with excessive phlegm (mucus)

▪ you have difficulty in urination due to enlargement of the prostate gland

▪ you have breathing problems such as emphysema or chronic bronchitis

▪ you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.

▪ taking a diuretic

▪ under a doctor’s care for any serious condition

▪ taking sedatives or tranquilizers

When using this product

▪ do not use more than directed

▪ excitability may occur, especially in children

▪ marked drowsiness may occur

▪ alcohol, sedatives, and tranquilizers may increase drowsiness

▪ avoid alcoholic drinks

▪ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

▪ an allergic reaction occurs. Seek medical help right away.

▪ 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

▪ ringing in the ears or a loss of hearing occurs

▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

▪ nervousness, dizziness, or sleeplessness occurs

▪ you experience any of the following signs of stomach bleeding

▪ feel faint

▪ vomit blood

▪ have bloody or black stools

▪ have stomach pain that does not get better

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

▪ do not exceed recommended dosage.

▪ do not take more than 6 doses in any 24-hour period.

▪ use enclosed dose cup

▪ keep dosage cup with product

▪ mL= milliliter

▪ adults and children 12 years and over: 30 mL every 4 hours

▪ children under 12: do not use

Other information

▪ each 30 mL contains: Sodium 16 mg

▪ store at room temperature 68o-86oF (20o-30oC)

Inactive ingredients

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions or Comments?

Call 1-888-535-0305 9a.m.- 5p.m. CST

PRINCIPAL DISPLAY PANEL

NDC 58809-514-08
NiteClear
COLD & FLU
Relief
8 fl oz(237 mL)

NITECLEAR COLD AND FLU RELIEF 
choline salicylate, diphenhydramine hci, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-514
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLINE SALICYLATE (SALICYLIC ACID) CHOLINE SALICYLATE870 mg  in 1 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
Packaging
#Item CodePackage Description
1NDC:58809-514-80237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/20/2015
Labeler - GM Pharmaceuticals, INC (793000860)

 
GM Pharmaceuticals, INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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