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cold multi symptom by H E B

Medically reviewed on December 25, 2017

Dosage form: solution
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: H E B
NDC Code: 37808-920

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.

HEB Cold Multi-Symptom Drug Facts

Active ingredients (in each 15 mL = 1 tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses
temporarily relieves these common cold/flu symptoms:
minor aches and pains
headache
sore throat
nasal congestion
runny nose and sneezing
cough
sinus congestion and pressure
helps clear nasal passages
relieves cough to help you sleep
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 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
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
glaucoma
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

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

When using this product
do not exceed recommended dose
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
nervousness, dizziness, or sleeplessness occur
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
do not take more than directed (see overdose warning)
mL = milliliter; TBSP = tablespoon
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

adults and children 12 years and over

take 30 mL (2 TBSP) in the dosing cup provided every 4 hours while symptoms last
do not take more than 150 mL (10 TBSP) in 24 hours, unless directed by a doctor

children under 12 years

ask a doctor

Other information
each 15 mL (1 TBSP) contains: sodium 5 mg
store at 20°-25°C (68°-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C blue no. 1, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to active ingredients of Tylenol® Cold Multi-Symptom Nighttime Cool Burst® Liquid

COLD MULTI-SYMPTOM

Night Time – Cool Ice®

Acetaminophen – Phenylephrine HCl – Dextromethorphan HBr – Doxylamine Succinate

Pain Reliever – Fever Reducer – Nasal Decongestant – Cough Suppressant - Antihistamine

Headache, Fever, Sore Throat – Cough

Nasal Congestion – Runny Nose

GLUTEN FREE

8 FL OZ (237 mL) Liquid

COLD MULTI SYMPTOM 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-920
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37808-920-34237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/21/2015
Labeler - H E B (007924756)

 
H E B

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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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