H E B MAX SEVERE CONGESTION and COUGH Maxium Strength: Package Insert and Label Information

H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquid
H E B

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.

Drug Facts

Active ingredients (in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg

Purpose

Dextromethorphan HBr … Cough suppressant
Guaifenesin ………………..Expectorant
Phenylephrine HCL ……….Nasal Decongestant

Uses
• helps loosen phlegm (mucus)
and thin bronchial secretions to
drain bronchial tubes
• temporarily relieves these
symploms occurring with a cold:
• cough due to minor throat and
bronchial irritation
• nasal congestion

Warnings
Do not use • if you are now
taking a prescription monoamine
oxiclase 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.
• for children under 12 years of
age

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

When using this product
• do not use more than
directed

Stop use and ask a doctor if
• nervousness, dizziness or
sleeplessness occur
• symptoms do not get better
within 7 days or are
accompanied by a fever
• cough comes back, or occurs
with fever, rash or persistent
headache. These could be
signs of a serious condition.

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.

Directions
• take only as recommended
• use dosage cup
• mL = milliliter
• do not take more than 6
doses in any 24-hour period

Age Dose

Adults & 20 ml every 4
children 12 hours
years and
older

Children Do not use
under 12
years of age

Other information

  • each 20 mL contains: sodium 10 mg
  • dosage cup provided
  • store between 15-30° C (59-86° F)
  • do not refrigerate

Inactive ingredients
anhydrous cilric acid, edetate
disodium, FD&C Blue #1, FD&C Red
#40. flavors. glycerin, propylene
glycol, propyl gallate, purified water,
sodium benzoate, sorbitol, sucralose,
Xanthan gum

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944

Product Label

Compare to Mucinex® FAST-MAX™

Severe Congestion and Cough active ingredients*

NDC 37808-317-25
H-E-B®

Maximum Strength

Max Severe
Congestion &
Cough
Dextromethorphan HBr /
Cough Suppressant
Guaifenesin / Expectorant
Phenylephrine HCI /
Nasal Decongestant

Congestion & Cough

Relief of:
• Cough
• Thins & Loosens Mucus
• Nasal & Chest Congestion

Adults

For Ages 12 & Over

6 FL OZ (177mL)

LF 001 Rev.01

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TEXAS, 782044

Peel Corner to Read Complete
Drug Facts and Information →

DO NOT USE IF PRINTED SEAL

UNDER CAP IS TORN OR MISSING

H-E-B®

100%
GUARANTEE
promise

If you aren’t completely pleased
with this product, we’ll be happy to
replace it or refund your money.
You have our word on it.


LB·001 Rev.01
1208
8581-1711

0 41220 38704 5
Lot:
Exp:

*This product is not manufactured or
distributed by Reckill Benckiser Inc..
distributor of Mucinex® FAST-MAXTM
Severe Congeslion &Cough

MADE WITH PRIDE & CARE FOR H·E-B® SAN ANTONIO. TX 78204

37808-317
(click image for full-size original)

res

H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-317
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
PROPYL GALLATE
WATER
SODIUM BENZOATE
SORBITOL
SUCRALOSE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-317-25 177 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/14/2012
Labeler — H E B (007924756)
Registrant — AptaPharma Inc. (790523323)
Establishment
Name Address ID/FEI Operations
AptaPharma Inc. 790523323 manufacture (37808-317)

Revised: 12/2019 H E B

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.