NDC | 50066-516-25 |
Set ID | c8eebe64-00bf-436d-a9fc-1623401bebfa |
Category | HUMAN OTC DRUG LABEL |
Packager | Genomma Lab USA, Inc |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Drug FactsActive ingredients(in each 20 mL)
- Purpose
- 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 product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical attention right away.
Sore throat warning: If sore throat is severe, persists 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, psychiatic, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
-
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to enlarged prostate gland
- Ask a doctor or pharmacist before use if
- When using this product
-
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- cough comes back or occurs with fever, rash or headache that lasts
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
- If pregnant or breast-feeding
- Keep out of reach of children
-
Directions
- do not take more than directed
- Do not take more than 6 doses in any 24 hours
- This adult strength product is not intended for use in children under 12 years of age
- Dose as follows or as directed by a doctor
- Use dose cup provided
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
- Inactive Ingredients
- Questions or comments?
-
Tukol MAX ACTION Cold, Sore Throat & Cough product label
Tukol® MAX ACTION
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSINGNEW MAX STRENGTH
ACETAMINOPHEN/Guaifenesin/Phenylephrine HCL/Dextromethorphan HBrTukol® MAX ACTION Cold, Sore Throat & Cough
- Fever & Headache
- Clears Nasal Congestion
- Thins & Loosens Mucus
- Controls Cough
Ages/12+
6 FL OZ (177 mL)Distributed by:
Genomma Lab USA, Inc.
Houston, TX 77027
Box number: BX-063 -
INGREDIENTS AND APPEARANCE
TUKOL MAX ACTION COLD, SORE THROAT AND COUGH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-516 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 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:50066-516-25 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/16/2016 Labeler - Genomma Lab USA, Inc (832323534) Registrant - AptaPharma Inc (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc 790523323 manufacture(50066-516) , relabel(50066-516) , repack(50066-516)