NIGHTTIME COLD AND FLU RELIEF THERAPY- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
QUALITY CHOICE (Chain Drug Marketing Association)
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.
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Drug Facts
Active ingredients (in each 15 mL, 1 tablespoon)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves
- minor aches and pains
- sneezing
- headache
- minor sore throat pain
- itchy, watery eyes
- nasal and sinus congestion
- runny nose
- cough due to minor throat and bronchial irritation
- itchy nose or throat
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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.
Do not use
- to make a child sleepy
- if you are now taking a prescription monoamine 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.
- with any other product containing diphenhydramine, even one used on skin
- with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if you have
- liver disease
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- cough accompanied by excessive
- phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
When using this product
- do not use more than directed (see overdose warning)
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- redness or swelling is present
- nervousness, dizziness, or sleeplessness occurs
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with a fever, rash or headache that lasts
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use in infants
- do not exceed recmmended dose (see overdose warning)
- use dosage cup provided
- tbsp= tablespoon, mL=milliliter
Do not take more than 6 doses (12 tablespoons) in 24 hours.
| age | dose |
| adults and children 12 years and over | 2 tablespoons (30 mL) every 4 hours |
| children 4 to 11 years | do not use unless directed by a doctor |
| children under 4 years | do not use |
Inactive ingredients
acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
Principal Display Panel
*Compare to the active ingredients in Theraflu® Nighttime
Nighttime
Flu Relief Therapy
Cold & Cough
Acetaminophen
Pain reliever/fever reducer
Diphenhydramine HCl
antihistamine/cough suppressant
Phenylephrine HCl
nasal decongestant
For ages 12 & over
Alcohol 10%
Cherry Flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Novartis Consumer Health Inc.© owner of the registered trademark Theraflu® Nighttime.
Failure to follow the drug facts warnings could result in serious consequences.
Distributed by C.D.M.A. Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300
| NIGHTTIME COLD AND FLU RELIEF THERAPY
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid |
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| Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774) |