Maximum Strength Severe Congestion Relief: Package Insert and Label Information

MAXIMUM STRENGTH SEVERE CONGESTION RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride capsule, liquid filled
Spirit Pharmaceuticals 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.

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

• for the temporary relief of the following cold/flu symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever

Warnings

Liver warning:

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:
• more than 4,000 mg of acetaminophen in 24 hours • 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 use 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. • if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use

if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur • pain, nasal congestion 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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed

adults and children 12 years & over • take 2 caplets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º–30ºC (59º–86ºF)

Inactive Ingredients

FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779

Made in India

Carton

Severe Congestion
(click image for full-size original)

MAXIMUM STRENGTH SEVERE CONGESTION RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4194
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITOL
SORBITAN
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape OVAL Size 26mm
Flavor Imprint Code 341
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-4194-1 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 12/28/2021
Labeler — Spirit Pharmaceuticals LLC (179621011)
Registrant — Spirit Pharmaceuticals LLC (179621011)
Establishment
Name Address ID/FEI Operations
MEDGEL PRIVATE LIMITED 677385498 manufacture (68210-4194)

Revised: 12/2021 Spirit Pharmaceuticals LLC

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