Label: NIGHTTIME WAL FLU SEVERE COLD AND COUGH- acetaminophen, diphenhydramine, phenylephrine powder, for solution
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- NDC Code(s): 0363-5410-06
- Packager: WALGREEN CO.
- 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 December 27, 2021
If you are a consumer or patient please visit this version.
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- Active ingredients (in each packet)
- Purposes
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Uses
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- temporarily relieves these symptoms due to a cold:
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- minor aches and pains
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- minor sore throat pain
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- headache
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- nasal and sinus congestion
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- runny nose
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- sneezing
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- itchy nose or throat
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- itchy, watery eyes due to hay fever
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- cough due to minor throat and bronchial irritation
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- temporarily reduces fever
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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 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions, Symptoms may include:
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- skin reddening
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- blisters
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- rash
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.
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Do not use
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- in a child under 12 years of age
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- if you are allergic to acetaminophen
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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 a pharmacist.
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- with any other product containing diphenhydramine, even one used on the 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 a MAOI, ask a doctor or pharmacist before taking this product.
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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
- Ask a doctor or pharmacist before use if you are
- When using this product
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Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occurs
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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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- symptoms do not get better or worsen
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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. There could be signs of a serious condition.
- If pregnant or breast- feeding,
- Keep out of reach of children.
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Directions
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- do not use more than directed
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- take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor
Age
Dose
children under 12 years of age
do not use unless directed by a doctor
adults and children 12 years of age and over
one packet
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- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
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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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Additional Information Listed On Other Panels
Walgreens
Compare to Theraflu® Nighttime Severe Cold &Cough active ingredient††
NIGHTTIME
Wal-Flu® Severe
Cold & Cough
ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER
DIPHENHYDRAMINE HCl /
ANTIHISTAMINE/ COUGH SUPPRESSANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT
ASPARTAME FREE
SODIUM FREE
- •
- Relieves nasal congestion, cough, body ache, sore throat pain, runny nose, sneezing, headache & fever.
Honey Lemon Flavor Infused with Chamomile & White Tea Flavors
6 PACKETS
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD,
TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
Walgreens.com ©2018 Walgreen Co,
WALGREENS PHARMACIST RECOMMENDED‡
‡Walgreens Pharmacist Survey
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Nighttime Severe Cold & Cough.
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INGREDIENTS AND APPEARANCE
NIGHTTIME WAL FLU SEVERE COLD AND COUGH
acetaminophen, diphenhydramine, phenylephrine powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5410 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color Score Shape Size Flavor HONEY, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-5410-06 6 in 1 CARTON; Type 0: Not a Combination Product 05/29/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/29/2018 Labeler - WALGREEN CO. (008965063)
