Family Dollar Services, Inc. Nighttime Flu & Severe Cold & Cough Drug Facts
Family Wellness flu and severe cold and cough by
Drug Labeling and Warnings
Family Wellness flu and severe cold and cough by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
FAMILY WELLNESS FLU AND SEVERE COLD AND COUGH NIGHTTIME- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solution
Family Dollar Services Inc
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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Family Dollar Services, Inc. Nighttime Flu & Severe Cold & Cough Drug Facts
Active ingredient (in each packet)
Acetaminophen 650 mg
Diphenhydramine hydrochloride 25 mg
Phenylephrine hydrochloride 10 mg
Uses
- temporarily relieves
- minor aches and pains
- minor sore throat
- headache
- nasal and sinus congestion
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 packets in 24 hours, which is the maximum daily amount for this product
- 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- 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.
- to make a child sleepy
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema, asthma or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not use more than directed
- 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
- you get nervous, dizzy or sleepless
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
Directions
- do not use more than directed – see Liver warning
- take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
- adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- children under 12 years of age: consult a doctor
- if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
Other information
- each packet contains: potassium 10 mg and sodium 24 mg
- phenylketonurics: contains phenylalanine 13 mg per packet
- store at 20º-25ºC (68º-77ºF)
Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate
Package/Label Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS OF THERAFLU® SEVERE COLD & COUGH NIGHTTIME
Nighttime
Flu & Severe Cold & Cough
Pain Reliever – Fever Reducer (Acetaminophen)
Antihistamine/Cough Suppressant (Diphenhydramine HCl)
Nasal Decongestant (Phenylephrine HCl)
Nasal Congestion
Cough
Runny Nose
Sneezing
Body Ache
Headache
Sore Throat Pain
Fever
HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS
| FAMILY WELLNESS FLU AND SEVERE COLD AND COUGH
NIGHTTIME
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solution |
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| Labeler - Family Dollar Services Inc (024472631) |