NDC | 37808-316-25 |
Set ID | 9b09b660-0758-48dc-84c9-26cdd2aacc03 |
Category | HUMAN OTC DRUG LABEL |
Packager | H E B |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART343 |
- Drug Facts Active ingredients
- Purpose
- Keep out of reach of children.
- Uses
-
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 productAllery 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
- Ask a doctor or pharmacist before use if you are
- When using this product
-
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
- Overdose warning
- Directions
- Other information
- Inactive ingredients
- Questions?
-
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 CongestionAdults
For ages 12 and Over6 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 consequences100%
GUARANTEE
promiseIf 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 liquidProduct 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)