Cold and Chest Congestion Relief
Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, GUAIFENESIN 200mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-299
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.
Active ingredients (in each tablespoon 15 mL)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCL 5 mg
Pain reliever/Fever reducer
Expectorant
Nasal Decongestant
Keep out of reach of children.
temporarily relieves
- minor aches and pains
- sore throat
- headache
- nasal and sinus congestion
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
Liver warnings: This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 6 dose in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
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.
- 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 4 years of age
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema
- cough that occurs with too much phlegm (mucus)
taking the blood thinning drug warfarin.
- do not use more than directed
- 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.
ask a health professional before use.
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.
Age Dose
Children under 4 years Do not use
Children 4 to under 12 years of age Do not use unless directed by a doctor
Adults and children 12 years and over 2 tablespoonful (30 mL) every 4 hours
- take only as recommended (see Overdose warning)
- use dose cup or tablespoon (TBSP)
- do not take more than 6 doses in any 24-hour period
- each tablespoon (15 mL) contains: sodium 10 mg, potassium
- dosage cup provided
- store between 20°-25° C (68°-7°7 F)
- do not refrigerate
Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Yellow #6, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
NDC 6801-299-08
*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION
Premier Value®
Cold and Chest Congestion Relief
Acetaminophen ............ Pain Reliver/Fever Reducer
Guaifensin ................... Expectorant
Phenylephrine HCL ...... Nasal Congestion
Thins and Loosens Mucus
Nasal and Chest Congestion
Sore Throat
Body Ache
Headache
Fever
Orange Flavor Liquid
8.3 FL OZ (245 mL)
PV Independently Tested Satisfaction Guaranteed
LF-005
DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING
Failure to follow these warnings could result in consequences
LB-005
DISTRIBUTED BY CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD SUITE 101
BOCA RATON, FL 33431
Lot:
Exp:
*This product is not manufactured or distributed b Novartis Consumer health Inc., owner of the registered trademark Theraflu® Cold and Chest Congestion
| COLD AND CHEST CONGESTION RELIEF
acetaminophen, guaifenesin , phenylephrine hydrochloride liquid |
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| Labeler - Chain Drug Consortium, LLC (101668460) |
| Registrant - AptaPharma Inc. (790523323) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| AptaPharma Inc. | 790523323 | manufacture(68016-299) | |
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.
