NIGHTTIME COLD/FLU RELIEF SOFTGELS- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Pharmacy Value Alliance, 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.
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Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Purpose
Acetaminophen …………….….Pain reliever/fever reducer
Dextromethorphan HBr .....Cough suppressant
Doxylamine succinate ……...Antihistamine
Uses temporarily relieves common cold/flu symptoms:
• cough due to minor throat and bronchial irritation
• sore throat • headache • minor aches & pains • fever
• runny nose and sneezing
Warnings Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4 doses, in 24 hrs, which is the maximum daily amount
for this product with other drugs containing acetaminophen • 3
or more alcoholic drinks daily while using this product
Allergy Alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2
days, occurs with or is 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
• 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 • glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs
with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland.
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.
• excitability may occur, especially in children
• marked drowsiness may occur • avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives & tranquilizers may increase drowsiness
Stop use and ask a doctor if
• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present • new symptoms occur
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact
a Poison Control Center right away. Quick medical attention is
critical for adults as well as children, even if you do not notice
any signs or symptoms.
Directions
• take only as directed (see Warnings)
• do not exceed 4 doses per 24 hrs
adults & children 12 years & over | 2 softgel with water every 6 hours |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
• when using other Daytime or Nighttime products,
carefully read each label to ensure correct dosing
Inactive ingredients D&C yellow # 10, FD&C Blue # 1,
Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide
Premier
Value®
*COMPARE TO THE ACTIVE INGREDIENTS
IN VICKS® NYQUIL® COLD & FLU
NIGHTTIME RELIEF LIQUICAPS®
Nighttime
COLD/FLU RELIEF
Acetaminophen/ Dextromethorphan HBr/
Doxylamine Succinate
• Aches, Fever & Sore Throat
• Sneezing, Runny Nose
• Cough
16 Softgels
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
Distributed by:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
If for any reason you are not completely satisfied with
this product, please return it to the store
where purchased for a full refund.
Failure to follow these warnings
could result in serious consequences.
TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPEN OR BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING.
KEEP OUTER BOX FOR COMPLETE
WARNINGS AND PRODUCT
INFORMATION.
BX-096
5
098188
1/20
16 Softgels Label
24 SofTgels Label
res
NIGHTTIME COLD/FLU RELIEF SOFTGELS
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled |
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Labeler - Pharmacy Value Alliance, LLC (101668460) |
Registrant - AptaPharma Inc. (790523323) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
AptaPharma Inc. | 790523323 | manufacture(68016-881) |