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shoprite ni calm by Wakefern Food Corporation

Medically reviewed on May 28, 2018

Dosage form: solution
Ingredients: ACETAMINOPHEN 650mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 30mL, DOXYLAMINE SUCCINATE 12.5mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL
Labeler: Wakefern Food Corporation
NDC Code: 41190-763

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.

ShopRite NI-CALM Severe Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion
sinus congestion and pressure
minor aches and pains
headache
fever
sore throat
runny nose and sneezing
cough due to minor throat and bronchial irritation
cough to help you sleep
reduces swelling of nasal passages
promotes nasal and/or sinus drainage
temporarily restores freer breathing through the nose

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 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.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product
do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if
you get nervous, dizzy or sleepless
pain, nasal congestion, or cough 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
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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
take only as directed – see Overdose warning
only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information
each 30 mL contains: sodium 12 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

butylated hydroxyanisole, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions?

1-800-SHOPRITE

Package/Label Principal Display Panel

Compare to: Active Ingredients in Vicks® NyQuil® Severe

SEE NEW WARNINGS

MAXIMUM STRENGTH

NI-CALM SEVERE

PAIN RELIEVER/FEVER REDUCER

Acetaminophen - Aches/Fever/Sore Throat

COUGH SUPPRESSANT

Dextromethorphan HBr - Cough

ANTIHISTAMINE

Doxylamine Succinate - Sneezing/Runny Nose

NASAL DECONGESTANT

Phenylephrine HCl - Nasal/Sinus Congestion & Sinus Pressure

Multi-symptom - ALCOHOL FREE

Berry Flavor

12 FL OZ (355 mL)

SHOPRITE NI CALM 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-763
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorRED (clear, dark) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41190-763-40355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/22/2014
Labeler - Wakefern Food Corporation (069722418)

 
Wakefern Food Corporation

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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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