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

H E B MAX SEVERE CONGESTION and COUGH by

Drug Labeling and Warnings

H E B MAX SEVERE CONGESTION and COUGH by is a Otc medication manufactured, distributed, or labeled by H E B, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients  (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg

PURPOSE

Purpose

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

INDICATIONS & USAGE

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

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 DOCTOR

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

When using this product
do not use more than
directed

STOP USE

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.

If pregnant or breast feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

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

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

res

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-317-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2012

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	Business Operations
AptaPharma Inc.		790523323	manufacture(37808-317)