Flu Relief Therapy Night Time by P & L Development, LLC Drug Facts
Flu Relief Therapy Night Time by
Drug Labeling and Warnings
Flu Relief Therapy Night Time by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
FLU RELIEF THERAPY NIGHT TIME- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
P & L Development, LLC
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.
----------
Drug Facts
Active ingredients (in each 15 mL, 1 tablespoon)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCI 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 everyday while using this product
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, 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 two 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 in this product
Ask a doctor before use if you have
- liver disease
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabtetes
- 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 dorwsiness
- 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) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center 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 recommended dose (see overdose warning)
- use dosage cup provided
- tbsp=tablespoon, mL= milliliter
| 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,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 active ingredients in Theraflu® Nighttime*
Flu Relief Therapy
Nighttime cold and cough
Acetaminophen
Diphenhydramine HCl
Phenylephrine HCl
Cherry flavor
relieves:
- aches, fever & sore throat
- cough & runny nose
- stuffy nose
for ages 12 & over
alcohol 10%
FL OZ (mL)
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE CAP IS BROKEN IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owber of the registered trademark Theraflu® Nighttime.
Fzailure to follow the drug facts warnings could result in serious consequences
| FLU RELIEF THERAPY NIGHT TIME
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid |
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| Labeler - P & L Development, LLC (101896231) |