Label: FAMILY WELLNESS FLU AND SEVERE COLD AND COUGH NIGHTTIME- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solution
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- NDC Code(s): 55319-964-51, 55319-964-91
- Packager: Family Dollar Services Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated November 8, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each packet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 6 packets in 24 hours, which is the maximum daily amount for this product
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- with other drugs containing acetaminophen
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- with any other product containing diphenhydramine, even one used on skin
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- 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.
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- to make a child sleepy
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema, asthma or chronic bronchitis
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
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- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
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- do not use more than directed
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- avoid alcoholic drinks
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- marked drowsiness may occur
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- alcohol, sedatives and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children
Stop use and ask a doctor if
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- you get nervous, dizzy or sleepless
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- pain, cough or nasal congestion gets worse or lasts more than 7 days
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- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
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Directions
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- do not use more than directed – see Liver warning
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- take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
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- 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.
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- children under 12 years of age: consult a doctor
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- 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
- Inactive ingredients
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
FAMILY WELLNESS FLU AND SEVERE COLD AND COUGH NIGHTTIME
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-964 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-964-91 6 in 1 CARTON; Type 0: Not a Combination Product 11/16/2017 2 NDC:55319-964-51 8 in 1 CARTON; Type 0: Not a Combination Product 11/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/16/2017 Labeler - Family Dollar Services Inc (024472631)
