MAX COLD, FLU, AND SORE THROAT- acetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hcl liquid

MAX Cold, Flu, and Sore Throat by

Drug Labeling and Warnings

MAX Cold, Flu, and Sore Throat by is a Otc medication manufactured, distributed, or labeled by H E B, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active ingredients

Active ingredients (in each 20 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal Decongestant

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 awaay.

Uses

temporarily relieves these common cold and flu symptoms:

• cough due to minor throat and bronchial irritation
• nasal congestion
• sinus congestion and pressure
• minor aches and pains
• sore throat
• headache
• fever
• helps loosed phlegm (mucus) ang thin bronchial secretions to drain bronchial tubes
  

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 daily while
using this product

Allery Alert: Acetaminophen may cause
severe skin reaction. 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 taking  a prescription monamine 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
• for children under 12 years of age

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma or empysema
• cough that occurs with too much phlegm (mucus)
  

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin.

When using this product

• do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• redness or swelling is present
• symptoms do not get better within 7 days or are accompanied by a fever
• fever gets worse or lasts more than 3 days
• new symptoms occur
• cough lasts more than 7 days, 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.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Age                                                                                  Dose

Adults and children 12 years and older                                20 mL every 4 hours

Children under 12 years of age                                           Do not use

Other information

• each 20 mL contains: sodium 10 mg
  
• dosage cup provided
• store between 20°-25° C (68°-7°7 F)
• do not refrigerate

Inactive ingredients

 Anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and 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™ 

Cold, Flu & Sore Throat active ingredients*

                                    NDC: 37808-316-25

H E B®

Maximum Strength

MAX COLD, FLU & SORE THROAT

Acetaminophen /
(Pain Reliver/Fever Reducer)
Dextromethorphan HBr /
(Cough Suppressant)
Guaifensin / (Expectorant)
Phenylephrine HCL /
Nasal Decongestant)

Cold, Flu & Throat

Relief of:
Fever and Body aches
Controls Cough
Thins and Loosens Mucus
Relieves Nasal and Chest Congestion

Adults
For ages 12 and Over

6 FL OZ (117 mL)              LF-002 Rev.2 02

Peel Corner to Read Complete Drug Facts and Information

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Failure to follow these warnings could result in consequences

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-002 Rev 02

               1208

Lot:
Exp:

INGREDIENTS AND APPEARANCE

MAX COLD, FLU, AND SORE THROAT 
acetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-316
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
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: 37808-316-25	117 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/05/2014

Labeler - H E B (007924756)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(37808-316)