Label: NYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, coated
Contains inactivated NDC Code(s)
NDC Code(s): 73097-009-02, 73097-009-20, 73097-009-25
- Packager: Savings Distributors LLC
- This is a repackaged label.
- Source NDC Code(s): 37000-813
- Category: HUMAN OTC DRUG LABEL
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.
Updated July 17, 2019
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- Drug Facts
- Active ingredients (in each caplet)
temporarily relieves common cold/flu symptoms:
• nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation
• cough to help you sleep • minor aches & pains • headache
• fever • sore throat • runny nose & sneezing
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 caplets 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
Allergy Alert: acetaminophen may cause severe skin reactions. Symptoms may include: • Skin reddening • Blisters • Rash
If a skin reaction occurs, stop ues and seek medical help right away
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.
• 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.
Ask a doctor before use if you have
• liver disease • heart disease • high blood pressure • thyroid disease
• diabetes • 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 ues 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, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
• you get nervous, dizzy or sleepless • pain, nasal congestion, or cough gets worse or lasts more than 7 days
• fever gets wore 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.
- Other Information
crospovidone, D&C Yellow No.10 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, FD&C Blue No.2 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
- Package Label
INGREDIENTS AND APPEARANCE
NYQUIL SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73097-009(NDC:37000-813) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 (UNII: L06K8R7DQK) CROSPOVIDONE (UNII: 68401960MK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 1mm Flavor Imprint Code NQ Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73097-009-25 50 in 1 CARTON 07/08/2019 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:73097-009-02 1 in 1 CARTON 07/08/2019 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:73097-009-20 40 in 1 CARTON 07/08/2019 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/08/2019 Labeler - Savings Distributors LLC (010527359)